MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-08 for PRISMAFLEX * M-60 manufactured by Gambro Renal Products, Inc..
[1120856]
Continuous renal replacement therapy (crrt) was disrupted when an alarm went off in the evening warning that the effluent was to negative. A check of the system did not show any problems. This alarm repeated two more times, with a shut down of the filter with warning number three. The patient blood was given back at this time. A new circuit was then needed to be set up.
Patient Sequence No: 1, Text Type: D, B5
[1305067]
Continuous renal replacement therapy (crrt) was disrupted when an alarm went off in the evening warning that the effluent was to negative. A check of the system did not show any problems. This alarm repeated two more times, with a shut down of the filter with warning number three. The patient blood was given back at this time. A new circuit was then needed to be set up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526373 |
| MDR Report Key | 1526373 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-08-24 |
| Report Date | 2009-11-08 |
| Date Reported to FDA | 2009-11-08 |
| Date Added to Maude | 2009-11-13 |
| 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 | PRISMAFLEX |
| Generic Name | HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | MQS |
| Date Received | 2009-11-08 |
| Model Number | * |
| Catalog Number | M-60 |
| Lot Number | NA |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | VICE PRESIDENT REGULATORY AFFA 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-08 |