MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-23 for ORIS BLOOD IRRADIATOR 1BL-437C * manufactured by Cis-us Inc..
[51600]
The cannister rotation indicator was observed to be immobile. A fuse was found to have blown. There is no audible or visual alarm to indicate malfunction and the instrument continues to simulate correct operation. It relies too heavily on operator intervention. Blood placed in the cannister may have been inadequately irradiated, exposing blood recipients to possible graft vs host reactions. Mfr. Instructions have been translated to english from french and do not provide explicit directions in some regards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011356 |
| MDR Report Key | 92783 |
| Date Received | 1997-05-23 |
| Date of Report | 1997-05-12 |
| Date of Event | 1997-04-21 |
| Date Added to Maude | 1997-05-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORIS BLOOD IRRADIATOR |
| Generic Name | BLOOD IRRADIATOR |
| Product Code | MOT |
| Date Received | 1997-05-23 |
| Model Number | 1BL-437C |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 91640 |
| Manufacturer | CIS-US INC. |
| Manufacturer Address | 10 DE ANGELO DR. BEDFORD MA 01730 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-23 |