MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-08 for DRAKE POST PUMP A/V BLOODLINE SET 205-506 03-2051-5 manufactured by Althin Cd Medical, Inc..
[15578]
Facility reported, 15 min into pt's hemodialysis treatmenet the arterial blood line at blood pump segment was noted to have a "split" in it. These lines where being used with a cobe century 2 system. Estimated blood loss 200cc to 250cc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-01065 |
| MDR Report Key | 24870 |
| Date Received | 1994-08-08 |
| Date of Report | 1994-07-05 |
| Date of Event | 1994-06-29 |
| Date Facility Aware | 1994-07-01 |
| Report Date | 1994-07-05 |
| Date Reported to FDA | 1994-07-05 |
| Date Reported to Mfgr | 1994-07-05 |
| Date Added to Maude | 1995-08-23 |
| 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 | DRAKE POST PUMP A/V BLOODLINE SET |
| Generic Name | HEMODIALYSIS |
| Product Code | FKK |
| Date Received | 1994-08-08 |
| Model Number | 205-506 |
| Catalog Number | 03-2051-5 |
| Lot Number | PS264E20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25292 |
| Manufacturer | ALTHIN CD MEDICAL, INC. |
| Manufacturer Address | 14-620 NW 60TH AVE. MIAMI LAKES FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-08 |