WARNING LETTER
Invacare Corporation
MARCS-CMS 617319 —
November 18, 2021
Delivery Method:
United Parcel Service
Product:
Medical Devices
Recipient:
Recipient Name
Matthew E. Monaghan
Recipient Title
Chairman, President/Chief Executive Officer
Invacare Corporation
One Invacare Way
Elyria
,
OH
44035
United States
mmonaghan@invacare.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 617319
November 18, 2021
Dear Mr. Monaghan:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 1200 Taylor Street (FEI: 1525712), One Invacare Way (FEI: 3002889431), and 39400 Taylor Parkway (FEI: 1000220413), from May 25, 2021 to June 24, 2021. During the inspection, FDA investigators determined that your firm is a manufacturer of a variety of Class II Oxygen Concentrators intended for patients with respiratory disorders requiring supplemental oxygen. 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 to affect the structure or any function of the body.
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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from July 16, 2021, August 31, 2021, September 30, 2021, and October 29, 2021 from Jason Fiest, Vice President Quality and Regulatory North America, concerning our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on June 24, 2021. We address the response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 C.F.R. § 820.198(c).
Specifically, your firm does not conduct an investigation of complaints when a device, including your oxygen concentrators, is either past the device end of life (EOL) or component wear period as defined in “Expiration of Consumables and End of Life for Devices” (RD-CP14-002-023a; Rev. C; Effective: 2/4/20) unless the device is associated with an alleged malfunction found to cause or contribute to an injury, illness, or death or the complaint contains a pre-defined key word as defined in “Complaint Evaluation, Investigation and Reporting” (WI-CP14-002-023; Rev. G, J; Effective: 4/11/19, 6/30/20). Moreover, your firm does not investigate complaints if a component was alleged to be the cause of the failure or if there was an assumption that any component failure was based on wear. For example, from February 1, 2020 to April 30, 2021, your firm did not investigate approximately 10% of your Oxygen Concentrator complaints (2,589/25,777) despite these complaints involving the possible failure of a device to meet its specifications.
The responses dated July 16, 2021, August 31, 2021, September 30, 2021, and October 29, 2021 are inadequate. According to your responses, CAPA CA-00067 was opened on June 25, 2021. The root cause analysis and procedural update to
(b)(4)
related to device end of life and component wear period followed by training have been completed. However, your procedure still does not require investigations of complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications (regardless of whether it was found to cause or contribute to an injury/illness or death).
Additional completed corrective actions included
(b)(4)
of the EOL and wear reference guide. In addition, your firm completed the temporary protocol for the
(b)(4)
review of complaint records which were not investigated based on EOL or component wear period. Planned actions include
(b)(4)
review of complaint records. Please provide an update on the corrective actions.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 C.F.R. § 820.198(a).
Specifically, your firm’s procedure titled “Customer Feedback and Complaint Entry” (WI-CP14-002-022; Rev.G; Effective: 12/1/20) which requires a device return for further investigation when the complaint contains the key word of injury, illness, or death with a harm and is assigned a severity score of
(b)(4)
for a given harm as defined in the “Harms and Severity Table Guidelines” (#RD-CP07-001b; Rev.F; Effective: 12/20/19) is inadequate. Harms such as allergic reaction, chemical burns, hypoxia, and hypercapnia are given a score of
(b)(4)
in the “Harms and Severity Table Guidelines” although the potential for severity of harms may be higher. For example, you received a complaint which alleged a user had to be taken to the hospital via ambulance to receive oxygen because your Platinum 10 Oxygen Concentrator was not producing the proper amount of oxygen (Complaint 263736). The alleged harm of hypoxia was assigned a severity of
(b)(4)
as defined in the “Harms and Severity Table Guidelines” and the unit was not requested for return for further investigation.
The responses dated July 16, 2021, August 31, 2021, September 30, 2021, and October 29, 2021 are inadequate. The immediate correction to justify the assigned severity score of
(b)(4)
for hypoxia in Complaint 263736, because your device labeling instructs the user to have a backup supply in case the device malfunctions is inadequate, since the user had to be given oxygen at the hospital to preclude permanent impairment of a body function or structure or possibly death.
According to your responses, CAPA CA-00068 was opened on June 25, 2021. A root cause analysis was completed as well as a review of randomly selected complaints which concluded harms and severity scores were accurately applied, updates to procedures, training and justification of the severity scores in the “Harms and Severity Table Guidelines” procedure. Please provide an update on these corrective actions and your plan to address the inadequacy of your justification for assignment of a severity score of
(b)(4)
for Complaint 263736.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that shall include requirements for using appropriate statistical methodology where necessary to detect recurring quality problems as required by 21 C.F.R. § 820.100(a)(1).
(a) Specifically, your firm’s procedure titled “Analysis Of Customer Complaints” (WI-HQ17-002-001; Rev.N; Effective: 8/6/19) for statistical analysis of complaints or any other such procedure does not require further analysis of complaints designated with an alleged symptom of “other” to determine if another category should be created or if a corrective action is warranted for any recurring issues despite the prevalence of such complaints in the top 6 alleged symptoms for Oxygen Concentrators in the 2020 Quarter 4 complaint analysis report.
The responses dated July 16, 2021, August 31, 2021, September 30, 2021, and October 29, 2021 are inadequate. According to your responses, CAPA CA-00070 was opened on June 25, 2021. The root cause analysis and procedural update to include analysis of complaints with an alleged symptom of “other” has been completed. However, the procedural update does not clearly explain how the “other” alleged symptom codes will be analyzed or how trending activities based on the “other” alleged symptom codes will be incorporated into the complaint process.
Completed corrective actions included
(b)(4)
review on complaints with the “other” category to determine if new alleged symptom codes are appropriate (with reclassification as necessary) and recalculation of baselines based on updated complaint data from reclassified alleged symptom codes. Planned actions include
(b)(4)
activities based on updated alleged symptom code baselines to determine if the updated data results in any new triggers; the addition of new alleged symptom codes to the
(b)(4)
complaint database; a procedural update to remove instructions to exclude the alleged symptom code of “other” from special cause trending; and training on updated procedures. Please provide an update on these corrective actions.
(b) Specifically, your firm does not analyze component failures for supplier monitoring although such information is captured in complaints where component(s) were found to be an underlying contributor. For example, from February 1, 2020 to April 30, 2021, approximately 81% (20,760/25,777) of complaints for the oxygen concentrators were linked to a component as the underlying cause.
The adequacy of your responses dated July 16, 2021, August 31, 2021, September 30, 2021, and October 29, 2021 cannot be assessed at this time. According to your responses, CAPA CA-00070 was opened on June 25, 2021 and a root cause analysis has been performed. Completed corrective actions included
(b)(4)
review of complaint data to determine the appropriate method for using the available component underlying cause data and the creation of a template to use for trending complaints by component underlying cause. Planned actions include validation of the component underlying cause template; establishment of baselines for trending by component; retrospective trending by component underlying cause; and procedural updates, followed up with training. Please provide an update on these corrective actions.
4. Failure to establish and maintain procedures for implementing corrective and preventive actions as required by 21 C.F.R. § 820.100(a).
Specifically, your corrective/preventive actions activities documented under CAPA #00046, regarding your Class II Recall Z-0514-2021 (initiated 9/14/20) for Perfecto Oxygen concentrators were inadequate. For example, one of the root causes was documented as a “poorly defined specification”. You did not investigate further to determine what part of your quality system allowed for this to occur and no corrective actions were implemented to prevent recurrence.
The adequacy of your responses dated July 16, 2021, August 31, 2021, September 30, 2021, and October 29, 2021 cannot be assessed at this time. According to your responses, CAPA CA-00069 was opened on June 25, 2021 to address the inadequacy of the CAPA procedure which allowed CAPA CA-00046 to be completed without identifying a quality system root cause. Also, CAPA CA-00073 was opened on July 1, 2021 to determine the systemic root cause of CAPA CA-00046. Completed corrective actions for CAPA CA-00069 included root cause analysis;
(b)(4)
review of corrective and preventive actions (CAPA) records; and procedural updates followed up with training. Completed corrective actions for CAPA CA-00073 included root cause analysis; updates to Failure Modes and Effects Analysis procedure and risk management plans with consideration of life requirements; and revision of the print review form on when supplier risk documentation should be obtained. Planned actions for CAPA CA-00073 include training on updated procedures and identification of appropriate product-specific training requirements for oxygen systems. Please provide an update on these corrective actions.
5. Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 C.F.R. § 803.50(a)(2).
For example, the information included for Complaints COMP-264183, COMP-265814, COMP-266384, COMP-266537, COMP-269058, COMP-270152, COMP-271453, COMP-277126, COMP-277205, COMP-278575, COMP-279342, COMP-279333 and COMP-280777 reasonably suggests that your firm’s oxygen concentrator malfunctioned (e.g.
(b)(4)
) while in use. The same malfunction is the subject of the recall Z-0514-2021 for the same device. Per the 1995 Preamble, a malfunction is reportable if the manufacturer takes, or would be required to take, an action under section 518 or 519(g) of the FD&C as a result of the malfunction of the device or other similar devices. (Refer to 1995 Federal Register Volume 60, Number 237, Page 63585. Please note that the preamble reference is section 519(f), but the appropriate designation for the section is now section 519(g) due to amendments to the FD&C Act). There is no information included for the complaint files that justifies that the malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur. As such, your firm should have submitted 13 MDRs, corresponding to each MDR reportable event reference in the complaints. However, your firm failed to submit an MDR to FDA for each reportable event referenced in the complaints.
The adequacy of your firm’s response dated July 16, 2021 cannot be determined at this time. The response noted that it will perform its retrospective review of complaints from November 13, 2020 through July 31, 2021 and staff training. We acknowledged that thirteen complaints referenced above were submitted as initial reports. However, your firm did not provide documentation or evidence that all the planned corrections and corrective actions, including the planned retrospective review and assessment of its reportability criteria, have been implemented and completed as they are still in progress.
The adequacy of your firm’s response dated August 31, 2021 cannot be determined at this time. The response noted that it completed its retrospective review, submitted MDRs for the reportable events received and updated its reportability criteria. However, your firm did not provide documentation or evidence that effectiveness check of corrections and corrective actions have been completed as it is still in progress. Furthermore, please provide an update on these corrective actions and justification for why a retrospective review of complaints for similar devices (not attributed to CAPA CA-00046) would not be required to determine if this malfunction is systemic in nature.
Your firm’s response dated September 30, 2021 appears to be adequate. In the response, your firm provided evidence that it completed all the corrections and corrective actions, including effectiveness check.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
If you have questions regarding any issues in this letter, please contact Compliance Officer, Sargum C. Morgan at 313-409-7331 or at sargum.morgan@fda.hhs.gov. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at gina.brackett@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.
Sincerely,
/S/
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division I
/S/
Malvina B. Eydelman, M.D.
Director
OHT 1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
11/30/2021
Regulated Product(s)
Medical Devices