MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-22 for CRRT PRISMAFLEX NA manufactured by Gambro.
[1340727]
Continuous renal replacement therapy (crrt) was in recirc mode. The machine alarmed air in line. There was no air present but there was obvious sediment present. A hand crank was used to move the sediment past the air leak detector and then the machine went into "general system failure. " the circuit was taken down, data was downloaded and a new circuit was placed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1730633 |
MDR Report Key | 1730633 |
Date Received | 2010-05-22 |
Date of Report | 2010-05-22 |
Date of Event | 2010-02-16 |
Report Date | 2010-05-22 |
Date Reported to FDA | 2010-05-22 |
Date Added to Maude | 2010-06-22 |
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 |
Reporter Occupation | RISK MANAGER |
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 | CRRT |
Generic Name | CRRT |
Product Code | FII |
Date Received | 2010-05-22 |
Model Number | PRISMAFLEX |
Catalog Number | NA |
Lot Number | NA |
ID Number | * |
Operator | NURSE |
Device Availability | Y |
Device Age | 1 YR |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | GAMBRO |
Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-05-22 |