MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-06-06 for RAD SOURCE/RS 3000 * manufactured by *.
[289777]
In 2002, the regular quality assurance program identified a potential problem in one rs 3000 blood irradiator related to low radiation output of the lower x-ray tube. The unit was immediately taken out of service. The date after rad source received the dosimetry results from the qa program, a company physicist was on site investigating the unit. The low radiation output was confirmed. This problem was not deteched by the tube current sensing function of the control system. The current through the tube is normal. The low output appears to be due to some internal defect in the tube. The problem was not detected by the rad-sure xr irradiation indicators routinely used because the indicators (which detect only 15 gy) were placed on the center of the blood bag on the top side of the canister, closest to the functioning tube. This point received a dose of 15 gy. The dose deficiency occurred on the bottom side at the periphery of the canister, closest to the malfunctioning tube. Because the irradiation indicator was placed in the center of the canister, it received a sufficient dose, while the periphery of the canister did not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063922-2002-00001 |
| MDR Report Key | 400972 |
| Report Source | 07 |
| Date Received | 2002-06-06 |
| Date of Report | 2002-06-05 |
| Date of Event | 2002-05-08 |
| Date Mfgr Received | 2002-05-08 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2002-06-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RANDOL KIRK |
| Manufacturer Street | 20283 STATE RD. 7 STE. 107 |
| Manufacturer City | BOCA RATON FL 33498 |
| Manufacturer Country | US |
| Manufacturer Postal | 33498 |
| Manufacturer Phone | 5614829330 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAD SOURCE/RS 3000 |
| Generic Name | BLOOD IRRADIATOR |
| Product Code | IYT |
| Date Received | 2002-06-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 390010 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-06 |