MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-24 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc..
[18579440]
Filter was changed due to rising filter/transmembrane pressures. Before the blood had reached the blood leak detector, an alarm occurred indicating blood in affluent and air in line. Air in line alarm cleared, but unable to clear blood leak alarm. The machine and tubing set was changed. The device ran smoothly. ====================== manufacturer response for cvvhd, prismaflex======================they have looked into the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1295883 |
| MDR Report Key | 1295883 |
| Date Received | 2009-01-24 |
| Date of Report | 2009-01-24 |
| Date of Event | 2008-07-13 |
| Report Date | 2009-01-24 |
| Date Reported to FDA | 2009-01-24 |
| Date Added to Maude | 2009-01-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | PRISMAFLEX |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | MQS |
| Date Received | 2009-01-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-24 |