ENS 43979
ENS Event | |
|---|---|
15:00 Feb 9, 2008 | |
| Title | Agreement State Report Involving Failure of Hdr Source to Retract During Testing |
| Event Description | The following information was provided by the State of Louisiana via email:
On February 9, 2008 at around 9:00 am, a Model Number AccuSource 1000, with a Model M-19 Iridium-192 High Dose Rate Brachytherapy Source failed to retract automatically while pre-operational acceptance testing was being performed at New York Radiation Oncology Associates, Queens, New York City, New York. The AccuSource 1000 is manufactured by Oncology Systems, Inc. Their license number is LA-11598-L01, amendment# - initial, with an expiration date of July 31, 2012. Agency Interest Number is 147139. Model M-19 Iridium-192 source SSD number is LA-0612-S-115-S. The sources maximum quantity is 12 curies of Iridium-192. Oncology Systems, Inc. according to their license condition number eight, states that 'The licensee shall report to the Department, immediately by phone and written notice with ten (10) days of occurrence of any irregularities pertaining to inability to retract the source to its fully shielded [position], and failure of any component or software (critical to safe operation of the device) to properly perform its intended function under the authority of this license.' This was reported by SPEC who is the manufacturer of the Model M-19 Iridium-192 source. Talking with SPEC, it does not seem that Oncology Systems, Inc. have any personnel located at the 119 Teal Street, St. Rose, LA 70087 location. The source, which was extended approximately 10 cm when it stuck, was manually retracted. There was no reported personnel overexposures, however, the individual's film badges involved in returning the source to the shielded position have been sent out for processing. The City of NY Rad Health Department was notified by the State of Louisiana of this incident.
The State provided the following information via facsimile: The incident involved an OSI AccuSource 1000, lr-192 HDR Brachytherapy unit. The unit malfunctioned, during an initial systems check, resulting in the source disconnecting from the source cable and the source capsule. The source strength was 8.62 curies. The source remained in a shielded position and was shipped back to Source Production & Equipment Company (SPEC), RAM License # LA- 2966-L01, the source manufacturer. No patients were involved and no overexposures were noted. This investigation is still in progress. One area of concern was noted. On February 9, 2008, an Oncology Systems. Inc. (OSI) Field Engineer, was performing quality assurance testing on the AccuSource 1000, lr-192 Brachytherapy High Dose Rate Remote Afterloader (HDR), at the new York Radiology Associates, located in Queens, New York (RAM License # 91-3338-01). Field Engineer first performed a systems and software check on the HDR using a nonradioactivce source. All quality assurance tests passed during this time. He then loaded the HDR with the inner vault/spool cartridge assembly, which had an 8.62 Curie lr-192 sealed source. Field Engineer performed several tests on the HDR unit before running the source cable out, to insure that the inner vault was installed correctly to the outer vault (which is part of the HDR unit). The tests passed. He then extended the source out of vault when a force error sensor was triggered between the vault and the turret. When the force error was triggered this triggered an emergency retraction of the source. During the emergency retraction of the Ir-192 source, the vault door closed on the source tip resulting in a source disconnect and the loss of the top part of the source capsule. The source did retract to the inner vault where it was shielded and did not leave the AccuSource unit. The inner vault/spool cartridge, with the Ir-192 source was packaged in a Type A shipping container, provided by SPEC, held at the facility in a locked room until it could be shipped to SPEC. SPEC received the container on 2/26/2008. The source capsule tip loss was not known until the inner-vault was inspected by SPEC on 03/18/08. Surface readings were 19mR/hr and 0.7mR/hr at one foot away. Survey readings of the package, before it was sent to SPEC, highest survey reading at one foot away from the package was 1.4mR/hr. This was taken at the bottom of the package. The highest reading taken from its side at one foot away was 0.51 mR/hr, similar to the reading at SPEC. Once the package was open, several wipes were performed by SPEC. Two areas above background were noted. The wipe from the tip of the cap/wire where the source capsule was missing (the lr-192 source would have direct contact with this piece) had a wipe count of 327cpm and back end of the cable had a wipe count of 101cpm. Background was 37cpm. Survey readings of the vault were done by SPEC and the department at the time of this investigation. Survey readings on the side of the vault were 200 mR/hr and 100 mR/hr at the end of the vault. The source was located in the inner vault, but the inner vault was not opened at the time of this inspection. The facility wanted the lr-192 source to decay before opening the inner vault. The inner vault was disassembled by SPEC on 03/18/2008. They found the bare lr-192 pellet in the straight exit channel of the front vault slug. The source capsule was not in the inner vault. The shipping package was re-surveyed and the capsule was not found. SPEC immediately notified the department and OSI. Wipe tests of the inside of the vault was performed by SPEC. The highest reading was taken from the center vault slug which was 33,000 nanoCuries. OSI field Engineer was going to the New York Facility during the week of 04/15/2008 to do a survey of the AccuSource and the therapy room to see if the missing capsule can be located. The results have not been received by the department as of 04/23/2008. OSI states that the force error could have been triggered by many reasons and that the cause is unknown. The source became 'stuck' due to the vault door closing partially on the capsule. OSI is in the process of making design and software changes to prevent this problem from occurring in the future." Notified R4DO (Powers) and FSME EO (Tadessee). |
| Where | |
|---|---|
| Oncology Systems, Inc. St. Rose, Louisiana (NRC Region 4) | |
| License number: | LA-11598-L01 |
| Organization: | Louisiana Radiation Protection Div |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+49.73 h2.072 days <br />0.296 weeks <br />0.0681 months <br />) | |
| Opened: | Joe Noble 16:44 Feb 11, 2008 |
| NRC Officer: | Steve Sandin |
| Last Updated: | May 15, 2008 |
| 43979 - NRC Website | |
Oncology Systems, Inc. with Agreement State | |
WEEKMONTHYEARENS 439792008-02-09T15:00:0009 February 2008 15:00:00
[Table view]Agreement State Agreement State Report Involving Failure of Hdr Source to Retract During Testing 2008-02-09T15:00:00 | |