MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-26 for PRISMAFLEX 107493 manufactured by Gambro Lundia Ab.
[775532]
The customer stated that the status screen and the set flow screen on the prismaflex were showing two different rates. The treating nurse confirmed, however, that there was no actual fluid discrepancy on this pt and that the machine was delivering the correct flow rate. A blood loss of 162 ml was reported, as the pt's blood was not returned. There was no pt injury, fluid imbalance or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2087532-2007-00208 |
| MDR Report Key | 954117 |
| Date Received | 2007-10-26 |
| Date of Report | 2007-09-28 |
| Date of Event | 2007-09-28 |
| Date Facility Aware | 2007-09-28 |
| Date Reported to Mfgr | 2007-09-28 |
| Date Added to Maude | 2007-11-28 |
| 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 | 2007-10-26 |
| Model Number | 107493 |
| Catalog Number | 107493 |
| Lot Number | * |
| ID Number | SW 2.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 27 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 924581 |
| Manufacturer | GAMBRO LUNDIA AB |
| Manufacturer Address | BOX 10101 LUND * SW SE-22010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-26 |