MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2008-02-01 for PRISMAFLEX 107493 manufactured by Gambro Lundia Ab.
[786748]
The customer reported that the blood flow rate on the status screen and the set flow screen on the prismaflex were showing two different rates. Shortly after the machine alarmed "blood pump malfunction". The nurse attempted to select continue and to re-enter the blood flow rate of 250 mls/min, but the status screen continued to display a blood flow rate of 340 mls/min and "blood pump malfunction alarms" reoccurred. Therefore the extracorporeal blood volume was returned to the pt and treatment was terminated there was no pt injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
[8091095]
The data files relating to the reported event were not available for review. The mfr has identified causes of flow rate discrepancies and has developed a software version to address this issue. Implementation will start after 510(k) clearances. Additionally, gambro voluntarily issued a medical device advisory notice (advisory notice 018) for the prismaflex continuous renal replacement system in 2007, which provides instructions to the user on how to clear flow rate discrepancies without interrupting treatment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2008-00004 |
| MDR Report Key | 989951 |
| Report Source | 01,05,06 |
| Date Received | 2008-02-01 |
| Date of Report | 2008-01-03 |
| Date of Event | 2007-12-20 |
| Date Mfgr Received | 2008-01-03 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2008-10-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | BOX 10101 |
| Manufacturer City | LUND |
| Manufacturer Country | SW |
| Manufacturer Phone | 8189000 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX |
| Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Product Code | MQS |
| Date Received | 2008-02-01 |
| Model Number | 107493 |
| Catalog Number | 107493 |
| ID Number | SW 3.00 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 993991 |
| Manufacturer | GAMBRO LUNDIA AB |
| Manufacturer Address | BOX 10101 LUND SW SE-22010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-01 |