ML092120085 

UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

OFFICE OF FEDERAL AND STATE MATERIALS 

AND ENVIRONMENTAL MANAGEMENT PROGRAMS 

WASHINGTON, DC 20555 

August 28, 2009 

NRC INFORMATION NOTICE 2009-15: VARIAN MEDICAL SYSTEMS VARISOURCE 

HIGH DOSE-RATE REMOTE AFTERLOADER 

EVENTS: SOURCE RETRACTION PROBLEMS 

ADDRESSEES 

All U.S. Nuclear Regulatory Commission (NRC) medical use licensees and NRC master 

materials licensees authorized to possess or use a Varian Medical Systems VariSource High 

Dose Rate Remote Afterloader (VariSource HDR). All Agreement State Radiation Control 

Program Directors and State Liaison Officers. 

PURPOSE 

The NRC is issuing this information notice to alert addressees about recently reported events at 

three different locations where service engineers experienced problems with the VariSource 

HDR during source retractions. During all of the incidents, the source wire became stuck 

outside of the afterloader and required the Varian personnel to use the manual-retract handle to 

return the source to a safe-shielded position. The NRC expects recipients to review the 

information for applicability to their facilities and to consider actions, as appropriate, to avoid 

similar problems. However, suggestions contained in this information notice are not new NRC 

requirements; therefore, neither specific action nor written response is required. 

The NRC is providing this information notice to the Agreement States for their information and 

for distribution to their medical use licensees, as appropriate. 

DESCRIPTION OF CIRCUMSTANCES 

The NRC received an event report involving VariSource HDR devices at three separate facilities 

where service personnel using standard procedures were unable to retract the source into the 

shielded tungsten safe, following source replacement. This event report, required in 

accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of 

General Applicability to Domestic Licensing of Byproduct Material,” and 10 CFR Part 21, 

“Reporting of Defects and Noncompliance,” involved three separate cases that occurred 

between December 2, 2008, and December 30, 2008. In all cases, the service personnel had 

completed a source exchange and were in the process of conducting positional verification 

testing of the new source. During the testing, the source wire failed to return to the shielded 

tungsten safe, requiring the service personnel to implement the emergency procedures. The 

service personnel first attempted to retrieve the source by depressing various emergency 

buttons located on the HDR device and device console. When this proved unsuccessful, the 
IN 2009-15 

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service personnel turned the manual-retract handle on the HDR device and successfully 

returned the source to the tungsten shield. 

Preliminary data suggest that the restrictions on the movement of the source wire occurred 

internally within the HDR, caused by buildup of material within one of the components along the 

source wire path. Specifically, in two cases, service personnel reported the presence of 

compacted black dust in the source guide fixtures near the source drive. None of the incidents 

occurred during patient treatment; however, the possibility of this happening in the future 

cannot be ruled out. 

DISCUSSION 

All of the incidents occurred because of an accumulation of dust buildup in the source wire 

path. It has been determined that the buildup is composed of dust materials produced from 

normal wear within the device. Analysis of the dust particles has shown that the dust is 

composed of the same material as the nickel titanium source wire. However, an analysis of the 

affected source wires, conducted by visual and mechanical examination, has shown that the 

integrity of the wires was not compromised in any of these events. 

This information notice reminds licensees to be aware of the potential problem associated with 

the accumulation of dust in these devices, leading to source wire constrictions. As a result of 

the problems caused by the buildup, Varian implemented special maintenance procedures, 

including the routine cleaning of any components exhibiting dust buildup on a regular basis. 

Initially, Varian service personnel conducted this cleaning at every source exchange; as the 

buildup rate of dust has become known, Varian has increased the frequency accordingly. 

Varian has released information regarding these events to its customers in Customer Technical 

Bulletin CTB-VS-640A. The bulletin reminds customers to review their emergency procedures 

in the event that the source wire must be retracted using the manual-retract handle. The 

bulletin also asks that customers immediately report any errors that occur upon active wire 

retraction with error code 1A, class 2, “Active wire drive slippage...,” which may indicate that the 

HDR is trending toward an internal path constriction. 

Furthermore, licensees should be aware of the following: 

• A user-resettable error code of 1A, class 2, “Active wire slippage...” should be reported 

to the manufacturer, Varian, immediately. 

• To shield the source, personnel would need to implement emergency procedures, which 

may require turning the manual-retract handle. 

• The VariSource HDR is approved for use with an 11-curie iridium-192 source. With 

such a source the exposure rate is 20.7 rem per hour at 50 centimeters. The exposure 

rate from an unshielded 10-curie iridium-192 source is 18.8 rem per hour at 50 

centimeters (as referenced in the Varian VS2000 SSD). 

• After an event where the source has become stuck outside of the afterloader, patient 

treatments should not resume until repairs are complete. 
IN 2009-15 

Page 3 of 3 

CONTACTS

This information notice requires no specific action or written response. If you have any 

questions about the information in this notice, please contact one of the technical contacts 

listed below or the appropriate regional office. 

 

 

 Robert Lewis, Director /RA/

 Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Technical Contacts: Stephen Poy, FSME 

 (301) 415-7135 

 E-mail: Stephen.Poy@nrc.gov

 

Enclosure: 

List of Recently Issued FSME 

 Generic Communications 
IN 2009-15 

Page 3 of 3 

CONTACTS

This information notice requires no specific action or written response. If you have any 

questions about the information in this notice, please contact one of the technical contacts 

listed below or the appropriate regional office. 

 

 

 

 Robert Lewis, Director /RA/

 Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Programs 

Technical Contacts: Stephen Poy FSME 

 (301) 415-7135 

 E-mail: Stephen.Poy@nrc.gov

 

Enclosure: 

List of Recently Issued FSME 

 Generic Communications 

ML092120085 

OFC FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME SPoy JJankovich AMcIntosh ADWhite JFoster JLuehman RLewis 

DATE 07/03/09 08/05/09 08/19/09 08/05/09 08/12/09 08/18/09 08/28/09 

OFFICIAL RECORD COPY 
IN 2009-15 

Enclosure 

Page 1 of 1 

List of Recently Issued Office of Federal and State Material 

and Environmental Management Programs Generic Communications 

Date GC No. Subject Addressees 

03/30/09 IN-2009-07 Withholding of Proprietary 

Information from Public Disclosure 

All current holders of and potential applicants 

for licenses, certificates of compliance, 

permits, or standard design certifications, as 

well as any other persons submitting a request 

that information be withheld from public 

disclosure under the provisions of Title 10 of 

the Code of Federal Regulations (10 CFR) 

Section 2.390, “Public inspections, exemptions, 

requests for withholding. 

07/27/09 IN-2009-12 Exempt Distribution Licensing 

Requirements For Irradiated Gemstones

All holders of NRC exempt distribution licenses 

authorized to distribute irradiated gemstones. 

Organizations associated with importing, 

distributing or selling irradiated gemstones or 

jewelry containing irradiated gemstones. All 

Radiation Control Program Directors and State 

Liaison Officers. 

07/29/09 IN-2003-22, 

Supplement 1 

Heightened Awareness for Patients 

Containing Detectable Amounts of 

Radiation from Medical Administrations

All U.S. Nuclear Regulatory Commission (NRC) 

medical-use licensees and NRC master 

material licensees; all Agreement State 

Radiation Control Program Directors and State 

Liaison Officers. 

04/29/09 RIS-2009-05 Uranium Recovery Policy Regarding: (1) 

The Process for Scheduling Licensing 

Reviews of Applications for New 

Uranium Recovery Facilities and (2) The 

Restoration of Groundwater at Licensed 

Uranium In-Situ Recovery Facilities 

All holders of operating licenses for uranium 

recovery facilities and all companies who have 

submitted applications to construct new 

uranium recovery facilities of all types 

(conventional mills, heap leach operations, and 

in-situ recovery facilities) or letters of intent to 

submit such applications. 

05/07/09 RIS-2009-07 Status Update for the Implementation 

of NRC Regulatory Authority for Certain 

Naturally Occurring and AcceleratorProduced Radioactive Material 

All U.S. Nuclear Regulatory Commission 

material and fuel cycle licensees. All Radiation 

Control Program Directors and State Liaison 

Officers. 

07/13/09 RIS-2009-09 Use Of Multiple Dosimetry and 

Compartment Factors in 

Determining Effective Dose Equivalent 

from External Radiation Exposures 

All U.S. Nuclear Regulatory Commission 

licensees, Agreement State Radiation Control 

Program Directors, and State Liaison Officers. 

Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and State 

Materials and Environmental Management Programs (FSME). A full listing of all generic communications may be viewed at 

the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/index.html