MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-03 for PRISMAFLEX 107493 manufactured by Gambro Lundia Ab.
[920543]
The customer reported that a male with acute renal failure expired 2 hours after terminating cvvhdf treatment on a prismaflex machine. The pt had been made dnr at the request of the family and his death was not unexpected. The hosp does not have any evidence of any device malfunction prior to the decision to terminate treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2087532-2008-00093 |
| MDR Report Key | 1150303 |
| Date Received | 2008-09-03 |
| Date of Report | 2008-08-06 |
| Date of Event | 2008-07-15 |
| Date Facility Aware | 2008-08-06 |
| Report Date | 2008-08-06 |
| Date Reported to Mfgr | 2008-08-06 |
| Date Added to Maude | 2008-09-09 |
| 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 | 3 |
| 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 | INTENSIVE CARE HEMODIALYSIS |
| Product Code | MQS |
| Date Received | 2008-09-03 |
| Model Number | 107493 |
| Catalog Number | 107493 |
| Lot Number | * |
| ID Number | SW3.20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1166498 |
| Manufacturer | GAMBRO LUNDIA AB |
| Manufacturer Address | BOX 10101 LUND SW SE-22010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-03 |