MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-03 for CGH LUNDIA ALPHA 600 (PL/CU1.3/L) 0122606 manufactured by Cobe Laboratories.
[21719103]
Facility reported that 30 mins into hemodialysis treatment there was a blood leak in the dialyzer. Ebl>100cc. There was no pt injury as reported by a healthcare professional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1996-00124 |
| MDR Report Key | 33470 |
| Date Received | 1996-05-03 |
| Date of Report | 1996-05-02 |
| Date of Event | 1996-04-16 |
| Date Facility Aware | 1996-05-01 |
| Report Date | 1996-05-02 |
| Date Reported to FDA | 1996-05-03 |
| Date Reported to Mfgr | 1996-05-03 |
| Date Added to Maude | 1996-06-19 |
| 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 600 (PL/CU1.3/L) |
| Generic Name | DIALYZER |
| Product Code | FJG |
| Date Received | 1996-05-03 |
| Catalog Number | 0122606 |
| Lot Number | 5-0563-N |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34810 |
| Manufacturer | COBE LABORATORIES |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-03 |