MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-18 for CGH LUNDIA AKPHA 700 (PL-CU/1.3M) 0122705 manufactured by Cobe Laboratories.
[25287]
Nurse reported that 5-10 min into hemodialysis treatment the blood leak alarm on the machine went off. The dialysate tested positive for a blood leak. Ebl >100cc. Treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1996-00192 |
| MDR Report Key | 34042 |
| Date Received | 1996-06-18 |
| Date of Report | 1996-06-14 |
| Date of Event | 1996-06-11 |
| Date Facility Aware | 1996-06-13 |
| Report Date | 1996-06-14 |
| Date Reported to FDA | 1996-06-14 |
| Date Reported to Mfgr | 1996-06-14 |
| Date Added to Maude | 1996-07-15 |
| 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 AKPHA 700 (PL-CU/1.3M) |
| Generic Name | DIALYZER |
| Product Code | FJG |
| Date Received | 1996-06-18 |
| Catalog Number | 0122705 |
| Lot Number | 6-0510-N11 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35380 |
| Manufacturer | COBE LABORATORIES |
| Manufacturer Address | PO BOX 101460 ATLANTA GA 30392 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-06-18 |