MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for CENTURY SYSTEM BLOOD TUBING 018-440-500 manufactured by Cobe Gambro Hospal.
[8844]
Facility alleged that after hemodialysis treatment was initated air was drawn into extracorporsal system. Source site appeared to be at venous end of dialyzer bloodline conneecting piece. Ebl 200cc. Treatment was restarted with new bloodline without further incident facility not certain if leak came from a crack in the dialyzer or leur end of venous bloodline as both were discarded. This was reported by a health care professional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1993-00249 |
| MDR Report Key | 15276 |
| Date Received | 1994-01-10 |
| Date of Report | 1993-12-06 |
| Date of Event | 1993-11-23 |
| Date Facility Aware | 1993-11-30 |
| Report Date | 1993-12-07 |
| Date Reported to Mfgr | 1993-12-07 |
| Date Added to Maude | 1994-08-17 |
| 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 | CENTURY SYSTEM BLOOD TUBING |
| Generic Name | BLOODLINE (VENOUS) |
| Product Code | FKY |
| Date Received | 1994-01-10 |
| Model Number | 018-440-500 |
| Catalog Number | 018-440-500 |
| Lot Number | 0943326 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15270 |
| Manufacturer | COBE GAMBRO HOSPAL |
| Manufacturer Address | 1201 OAK STREET LAKEWOOD CO 80215 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-01-10 |