MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-18 for CD manufactured by Althin Medical.
[13666]
Facility alleges spontaneous disconnection of blood linduring reuse. Chief tech reports arterial line blow off during treatment. Estimated ed blood loss 400 cc. No patient injury orted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-00424 |
| MDR Report Key | 20350 |
| Date Received | 1994-10-18 |
| Date of Report | 1994-10-03 |
| Date of Event | 1994-07-30 |
| Date Facility Aware | 1994-09-30 |
| Report Date | 1994-10-03 |
| Date Reported to FDA | 1994-10-03 |
| Date Reported to Mfgr | 1994-10-03 |
| Date Added to Maude | 1995-03-17 |
| 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 | CD |
| Generic Name | BLOOD PORT ADAPTER |
| Product Code | FKB |
| Date Received | 1994-10-18 |
| Lot Number | C188 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20237 |
| Manufacturer | ALTHIN MEDICAL |
| Manufacturer Address | 14600 NW 60TH AVENUE MIAMI LAKES FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-18 |