RAPIDSTRAND RX
Report
- Report Number
- 2915056-2011-00030
- Event Type
- Malfunction
- Date Received
- September 26, 2011
- Date of Event
- May 10, 2011
- Report Date
- September 26, 2011
- Manufacturer
- GE HEALTHCARE
- Product Code
- KXK
- PMA / PMN Number
- K063177
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
FDA MDR NUMBER: 1417338-2011-00030. CORRECTED DATA: FDA MDR NUMBER: COLLECTION TO MANUFACTURER ID COMPONENT OF NUMBER. GE HEALTHCARE QUALITY ASSURANCE INVESTIGATION REPORT (B)(4). GE HEALTHCARE WAS MADE AWARE OF A POTENTIAL FOR INCORRECT LOADING OF RAPIDSTRAND RX NEEDLES DUE TO NON-COMPLIANCE WITH STANDARD OPERATING PROCEDURE ON THE PART OF ONE TECHNICIAN AT THE RADIOPHARMACY IN WHICH BRACHYTHERAPY IMPLANTS WERE PREPARED. FOUR INCIDENTS WERE REPORTED IN WHICH SEEDS HAD BEEN SWAPPED BETWEEN ORDERS RESULTING IN INCORRECTLY LOADED NEEDLES (MDR REPORT ID: 2915056-2011-00001, 2915056-2011-00002), OR INCORRECT CALIBRATION STRANDS BEING PROVIDED WITH THE ORDER (MDR REPORT ID: 2915056-2011-00003, 2915056-2011-00006), RESULTING IN MISLABELING OF THE DEVICE. INVESTIGATION OF THESE INCIDENTS AT THE LOADING FACILITY SHOWED THAT THE TECHNICIAN HAD WORKED ON TWO ORDERS AT THE SAME TIME AND MIXED THE SEEDS BETWEEN THEM. CORRECTIVE ACTIONS IMPLEMENTED AT THE LOADING FACILITY COMPRISED TERMINATION OF THE EMPLOYMENT OF THE TECHNICIAN INVOLVED AND RE-TRAINING OF THE OTHER TECHNICIANS ON THE SOP FOR LOADING IMPLANT NEEDLES. GE HEALTHCARE REVIEWED ALL (B)(4) ORDERS THAT THE TECHNICIAN COMPLETED DURING EMPLOYMENT AND IDENTIFIED 23 WHERE THERE WAS THE POSSIBILITY FOR SEEDS BEING MIXED BETWEEN TWO OR MORE ORDERS. THIS WAS DETERMINED BY IT BEING POSSIBLE FOR THE TECHNICIAN TO HAVE WORKED ON TWO OR MORE SAME-PRODUCT ORDERS SIMULTANEOUSLY WHERE SEEDS OF DIFFERENT ACTIVITY WERE INVOLVED. IT SHOULD BE NOTED THAT IT CANNOT BE DETERMINED THAT SEEDS WERE MIXED BETWEEN THE ORDERS, ONLY THAT THE POSSIBILITY EXISTS. MIXING SEEDS BETWEEN ORDERS IS PRESUMED TO AFFECT RADIATION EXPOSURE TO THE AREA SURROUNDING THE IMPLANT (PROSTATE GLAND, URETHRA, AND RECTUM), EITHER AN OVER-DOSE WHERE HIGHER ACTIVITY SEEDS WERE INTRODUCED INTO THE LOADED NEEDLES CARRYING INCREASED RISK OF RADIATION SIDE-EFFECTS, OR UNDER-DOSE WHERE LOWER ACTIVITY SEEDS WERE INTRODUCED INTO THE LOADED NEEDLES CARRYING RISK OF SUB-OPTIMAL TREATMENT OF THE TUMOR. THE ORDERED SEED ACTIVITY AND TREATMENT PLAN FOR EACH OF THE TWENTY-THREE PATIENTS WAS REVIEWED AGAINST THE SEED ACTIVITY IN THE ORDER RELEVANT TO THE POSSIBLE MIX-UP. WORST-CASE SCENARIO, 100 PERCENT SWAP, WAS ASSUMED AND THE CONSEQUENT OVER-DOSE OR UNDER-DOSE CALCULATED. GE HEALTHCARE RISK ASSESSMENT CONCLUDED THAT, FROM A MEDICAL VIEWPOINT, THE RISK OF SERIOUS INJURY OR DEATH AS A RESULT OF A RECURRENCE OF SUCH MISLABELING IS REMOTE.
ON (B)(6) 2011 A MALE PATIENT WAS IMPLANTED WITH 55 RAPIDSTRAND RX SEEDS OF 8.25 MBQ (0.223 ACTIVITY ON IMPLANT DATE) FOR BRACHYTHERAPY OF PROSTATE CANCER. PER (B)(4), THE SEEDS MAY HAVE BEEN MIXED WITH ANOTHER SEEDS ORDER OF 13.65 MBQ (0.369 MCI), RESULTING IN A POTENTIAL RADIATION OVER-DOSE. TO DATE, NO ADVERSE EXPERIENCE HAS BEEN NOTIFIED TO THE COMPANY FOR THIS PATIENT. THE ORDERED SEED ACTIVITY AND TREATMENT PLAN FOR THIS PATIENT WAS REVIEWED BY THE GE HEALTHCARE MEDICAL GROUP AGAINST THE SEED ACTIVITY IN THE ORDER RELEVANT TO THE POSSIBLE MIX-UP. WORST-CASE SCENARIO, 100 PERCENT SWAP, WAS ASSUMED AND THE POTENTIAL OVER-DOSE OR UNDER-DOSE CALCULATED. THIS IS PROVIDED IN THE ATTACHMENT TO THIS MDR REPORT. GE HEALTHCARE HAS NOTIFIED THE PHYSICIAN WHO PERFORMED THE SEED IMPLANT IN WRITING AND BY TELEPHONE AND IS FOLLOWING UP FOR FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDSTRAND RX | RADIONUCLIDE BRACHYTHERAPY SOURCE | KXK | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |