MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-08 for PRISMAFLEX 107493 manufactured by Gambro Lundia Ab.
[952146]
The customer reported that a female with chronic hemodialysis pt expired 3 hrs after terminating cvvhdf treatment on a prismaflex machine. The pt had been made a do not resuscitate (dnr) at the request of the family, so her death was not unexpected. Neither the physician nor the nurses caring for the pt believe that a prismafex machine malfunction caused or contributed to the death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2087532-2008-00092 |
| MDR Report Key | 1173763 |
| Date Received | 2008-09-08 |
| Date of Report | 2008-07-09 |
| Date of Event | 2008-07-08 |
| Date Facility Aware | 2008-07-09 |
| Report Date | 2008-07-09 |
| Date Reported to Mfgr | 2008-07-09 |
| Date Added to Maude | 2008-09-26 |
| 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 | 2008-09-08 |
| Model Number | 107493 |
| Catalog Number | 107493 |
| Lot Number | * |
| ID Number | SW3.20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1200219 |
| Manufacturer | GAMBRO LUNDIA AB |
| Manufacturer Address | BOX 10101 LUND SW SE-22010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-08 |