MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-06 for CGH LUNDIA ALPHA 700 (PL/CU/1.3 M) * 0122705 manufactured by Cobe Laboratories.
[56287]
Facility alleges that two dialyzers from the same lot number and case developed leaks shortly after dialysis was initiated. The two leaks occurred with the same pt on the same day. Estimated blood loss was reported as 400-500 cc. Both dialyzers and the remainder of the case are being held at the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1997-00461 |
| MDR Report Key | 96537 |
| Date Received | 1997-06-06 |
| Date of Report | 1997-06-05 |
| Date of Event | 1997-06-04 |
| Date Facility Aware | 1997-06-04 |
| Report Date | 1997-06-05 |
| Date Reported to FDA | 1997-06-07 |
| Date Reported to Mfgr | 1997-06-07 |
| Date Added to Maude | 1997-06-10 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CGH LUNDIA ALPHA 700 (PL/CU/1.3 M) |
| Generic Name | HEMODIALYZER |
| Product Code | FJG |
| Date Received | 1997-06-06 |
| Model Number | * |
| Catalog Number | 0122705 |
| Lot Number | 60168L01 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 95305 |
| Manufacturer | COBE LABORATORIES |
| Manufacturer Address | P.O.BOX 101460 ATLANTA GA 30392 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-06-06 |