Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2015/ucm474240
Timestamp: 2019-02-18 12:21:15
Document Index: 653541626

Matched Legal Cases: ['§ 321', '§ 351', 'art 820', '§ 351', '§ 360', '§ 360', '§ 352', '§ 360', '§ 360', 'art 803', 'art 803']

WalkMed Infusion, LLC 11/2/15
Mr. Ross W. Kurz
WalkMed Infusion, LLC
6555 S. Kenton St, Suite 304
Ref # DEN-16-01-WL
During an inspection of your firm located at 6555 S. Kenton St., Suite 304, Centennial, Colorado, from May 18 through June 11, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices including electronic infusion pumps (ambulatory and pole mounted), reservoir bags, and administration sets. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body of man or other animals.
During the current inspection, we reviewed the Class II medical devices, Triton and Triton FP volumetric infusion pumps, which are manufactured and distributed by your firm under 510(k) K070529. Our inspection also covered the administration sets intended for use with the Triton and Triton FP pumps.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. You can find these regulations on the FDA website at www.fda.gov.
We acknowledge receipt of your responses dated July 1, 2015, and August 31, 2015, in reference to our Form FDA 483, Inspectional Observations, issued on June 11, 2015. We have reviewed these responses and determined that the information provided and corrective actions described are not adequate to address our concerns pertaining to the infusion pumps and administration sets produced and distributed by your firm. These concerns include not only those recorded on the Form FDA 483 but also those discussed with you during the inspection. Your third response to the Form FDA 483 was received by our office on October 26, 2015. This response along with any proposed field corrections are currently pending review. We address your first two responses below, in relation to each of the noted violations.
Violations noted during your recent inspection include, but are not limited to, the following:
1. You failed to investigate complaints involving the possible failure of a device to meet certain specifications, where necessary, as required by 21 CFR 820.198(c).
Our review has determined that you failed to conduct adequate investigations for complaints related to issues where your devices may have failed to perform to their specifications. Specifically, between January 2013 and May 2015, your firm (1) received (b)(4) complaints for issues related to situations involving the Triton and Triton FP Infusion pumps in which air was infused into patients or the air-in-line detection system failed; and (2) your firm received (b)(4) complaints for issues involving patient infusion related reactions during use of your Triton Administration Sets.
Your response is inadequate to address our concerns as demonstrated by the following:
a. You state that complaints related to the air-in-line detection system were re-evaluated; however, you did not provide a justification for your failure to review all complaints cited on the Form FDA 483. Specifically, the following complaints were not included in your review: complaint numbers (b)(4).
b. You continue to refer to Corrective Action Report (CAR) (b)(4) to explain why you did not conduct an additional investigation of the cited complaints; however, this CAR is inadequate as it does not include as part of your complaint investigation an assessment for the adequacy of the testing equipment you use, the adequacy of the (b)(4) design, or the adequacy of the overall testing parameters. Of particular concern, this CAR still uses (b)(4) Test protocol (b)(4) which is not reflective of the clinical capabilities of the device.
c. Copies of corrective action documents opened as a result of this observation, including Corrective and Preventive Action (CAPA) (b)(4) were not provided and could not be reviewed.
d. Your response fails to include how you intend to address particulate non-conformances with your (b)(4) supplier and you have not provided documentation demonstrating that the issue has been adequately investigated. You also failed to provide a retrospective assessment on the scope of the problem and the potential impact on marketed product.
e. You state that you have updated your complaint handling procedure (100-601). This record includes a drop-down completion form with no explanation to the employee on how to appropriately assess the question being asked (in all cases) nor does it specify which employee(s) (with or without specialized training) will perform certain assessments in the Complaint Handling Record. Examples include: documenting a risk and severity rating and assessing for the potential for serious injury.
2. You failed to adequately establish procedures for corrective and preventive action (CAPA) that includes analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential cause of nonconforming product, as required by 21 CFR 820.100(a)(1).
Our inspection determined that you failed to implement your CAPA procedure (document # 100-600, revisions D-F) in that you did not analyze and identify the existing and potential causes of nonconforming product and implement corrective actions as needed. For example, between January 2013 and May 2015, your firm received (b)(4) consumer complaints pertaining to excess flow rate or over-infusions using your Triton and Triton FP infusion pumps, some of which have been confirmed as (b)(4). You have categorized a number of these complaints as (b)(4) however, you have yet to implement a corrective action to address these (b)(4). Further, you have not adequately identified the cause of these problems.
In addition, the statistical methodology used by your firm may not be appropriate to detect recurring quality problems as you are (b)(4) to interpret trends in generic complaint count data to infer potential quality issues.
a. You state that CAPAs (b)(4) were opened to address this concern; however, you did not provide copies of either of these documents for our review.
b. Your retrospective review of complaints from January 2014 to June 2015 resulted in your firm submitting an additional eight Medical Device Reports. Of the (b)(4) complaints re-evaluated, (b)(4) were determined to be incorrectly assessed for severity rating. (b)(4) of the complaints reviewed resulted in elevating the severity level to (b)(4). You reference CAR (b)(4) to address this issue, but did not provide a copy of the document for our review. You also did not provide any documentation supporting a potential root cause or proposed corrective actions to appropriately address the (b)(4) issues associated with your devices.
c. You state in your response that CAPA procedure 100-600 will be revised to include an assessment for (b)(4); however, you did not provide a copy of the CAPA procedure nor did you provide a timeframe for completion of employee training for this procedure.
3. You failed to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
Our inspection has determined that your firm did not establish adequate procedures to control product that does not conform to specified requirements because your firm continues to distribute Triton FP infusion pumps with potentially (b)(4) as a result of your failure to determine the root cause for the defects. You also failed to establish procedures for proper equipment maintenance as demonstrated by the malfunctioning equipment (asset (b)(4)) used for testing the (b)(4) prior to finished product distribution.
a. You only reviewed NCRs (b)(4) but neglected to include an assessment or comment for lack of assessment for the following: (b)(4).
b. You state that NCR (b)(4) was the only non-conformance which did not have an adequate investigation and is going to be addressed through NCR (b)(4); however, the investigations associated with other NCRs still do not appear to be complete.
c. Your investigation into NCR (b)(4) was inadequate because it used the (b)(4) Test protocol (b)(4) which is not reflective of actual clinical use capabilities.
d. NCRs (b)(4) are supposedly addressed through CAPA (b)(4) related to the use of a (b)(4). This CAPA was not provided for our review. You have committed to (b)(4) to Preventive Maintenance (PM) as well as assessing other equipment for the need for addition to PM; however, you did not provide timeframes for completion, nor did you commit to conducting a retrospective review for how this faulty equipment may have affected product in commerce for which you are still receiving (b)(4).
4. You failed to establish adequate procedures for validating device design. Such design validation must include a risk analysis, as required by 21 CFR 820.30(g).
The (b)(4) study used by your firm to conduct risk analysis and identify potential severity of harm pertaining to over and under infusions is not adequate as this study did not consider the intended uses of (b)(4).
a. You state that procedural changes to your risk analysis will occur but do not provide applicable copies or timeframes for completion of these changes and employee training.
b. It is not clear from your response if you will be conducting another retrospective review of complaints after you make these procedural changes to your firm’s risk assessment program to determine if additional MDRs need to be submitted to FDA.
5. You failed to adequately establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).
Our inspection has determined that you have not demonstrated that you verified that design output meets the following design input requirements established in your Design Input Requirements protocol (document # 310119, revision M): (b)(4).
a. You state that CAPA (b)(4) was opened to address the issue; however, a copy of the document was not provided for our review.
b. You state that verifications and procedural changes will be conducted; however, you did not provide documentation or proposals nor did you provide estimated timeframes for completion of such changes.
6. You failed to establish and maintain procedures for validating the device software for the Triton FP infusion pumps to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).
Our inspection determined that the software defects identified in the Verification and Validation Report (document (b)(4)) were not fixed prior to release of the Triton FP Infusion Pumps’ software version 17.09.04 and you did not assess the potential impact of these defects on the intended use of the pumps.
Your response is inadequate to address our concerns as demonstrated by the following: You state that this issue is related (b)(4). Defects identified during the execution of the validation protocol (b)(4). The documentation provided did not demonstrate that you considered revalidation of the software as a potential solution or assessment of the impact to commercial product which has demonstrated (b)(4).
7. Your calibration procedures fail to include specific directions and limits for accuracy and precision, as required by 21 CFR 820.72(b).
Our review has determined that your firm has yet to establish limits or accuracy and precision for (b)(4) pieces of (b)(4) equipment currently in use for the manufacture of your finished devices.
a. You state that CAPA (b)(4) was opened; however, a copy was not provided for our review.
b. You state that prospective actions have been implemented for current equipment used on the production floor, but neglect to include a list of equipment found out of tolerance or an assessment for how the equipment, as found, would affect or potentially affect the quality of finished product which may still be in commerce.
Our inspection also revealed that the Triton FP Model 400000 infusion pumpis adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Triton FP Model 400000 infusion pumpis also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to the FDA, as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i). Specifically, you have modified the Triton Model 300000, cleared under K070529,by making software and specification changes that resulted in the Triton FP Model 400000 without notifying FDA.
Examples of software changes include:
Modifications to infusion pump software are generally considered to have a potential to significantly impact safety or effectiveness of infusion devices. This is primarily because software malfunctions can result in the infusion device shutting down or stopping the infusion, causing an under-delivery or delay of therapy.
Your firm also made specification changes, that include:
The specification changes implement new features / functionality or modify safety- critical specifications (b)(4), as compared to the cleared Triton Model 300000.
As required by 21 CFR 803.81(a)(3), a change or modification in the device that could significantly affect the safety or effectiveness of the device requires a new 510(k).
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Additionally, premarket approval applications for devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will also not be granted until the violations related to the subject devices have been corrected.
We also note that your firm had initially failed or refused to furnish material or information regarding the devices that is required by Section 519 of the Act, 21 U.S.C. § 360i, and/or 21 CFR Part 803 - Medical Device Reporting. Specifically, you had failed to report to FDA that there was an incident where your Triton pump, Model #300000, did not detect air in the line (Complaint Handling Record (b)(4), dated 08/22/13) within the required timeframe (see 21 CFR 803.50(a)(2)). This malfunction, if it were to recur, would be likely to cause or contribute to a death or serious injury. This noncompliance with the Medical Reporting requirements in section 519 of the Act and 21 CFR Part 803 had rendered your Triton pump misbranded under section 502(t)(2) of the Act; however, your firm has since submitted an MDR for Complaint (b)(4), which we deem to satisfy this requirement. Your Triton pump, therefore, is no longer misbranded for this reason.
Please note that the eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule took effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of any additional steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring in the future. You should include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations to bring your products into compliance.
Your response should be sent to: Food and Drug Administration, Denver District, P. O. Box 25087, (6th Ave. and Kipling Pkwy., DFC, Bldg 20), Denver, CO 80225-0087, Attention: Matthew R. Dionne, Pharm.D., Compliance Officer. If you have any questions, please contact Dr. Dionne at (303) 236-3064.
WalkMed, LLC - Close Out Letter 5/1/17
Page Last Updated: 05/03/2017