MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-08 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc.
[1120390]
Prismaflex continuous renal replacement therapy machine lost memory for one hour's worth of fluid totals and the recorded patient weight. The next two hours the machine took off more fluid than it should have without any alarm sounding. The prismaflex support line was called and machine was taken out of service. A new machine was set up. This delay caused a roughly three and one-half hour lapse of therapy and resulted in the patient requiring an increase in pressor therapy.
Patient Sequence No: 1, Text Type: D, B5
[1302810]
Prismaflex continuous renal replacement therapy machine lost memory for one hour's worth of fluid totals and the recorded patient weight. The next two hours the machine took off more fluid than it should have without any alarm sounding. The prismaflex support line was called and machine was taken out of service. A new machine was set up. This delay caused a roughly three and one-half hour lapse of therapy and resulted in the patient requiring an increase in pressor therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526002 |
| MDR Report Key | 1526002 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-09-13 |
| 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 | PRISMAFLEX |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 6 MO |
| 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 |