MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-13 for ATHIN DRAKE PRE PUMP A/V BLOODLINE SET 205-S05 manufactured by Althin Medical, Inc..
[12895]
Facility reported, during hemodialysis treatment connector site of blood line to fistula needle leaked. Pt blood loss was100cc. Pt condition tion stable. No further medical intervention was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-01054 |
| MDR Report Key | 19098 |
| Date Received | 1994-06-13 |
| Date of Report | 1994-05-26 |
| Date of Event | 1994-05-12 |
| Date Facility Aware | 1994-05-25 |
| Report Date | 1994-05-26 |
| Date Reported to FDA | 1994-05-26 |
| Date Reported to Mfgr | 1994-05-26 |
| Date Added to Maude | 1995-01-24 |
| 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 | ATHIN DRAKE PRE PUMP A/V BLOODLINE SET |
| Generic Name | HEMODIALYSIS |
| Product Code | FKB |
| Date Received | 1994-06-13 |
| Catalog Number | 205-S05 |
| Lot Number | PS254C04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19023 |
| Manufacturer | ALTHIN MEDICAL, INC. |
| Manufacturer Address | 14-620 N.W. 60TH AVENUE MIAMI LAKES FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-06-13 |