MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-03 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc..
[1036764]
In the summer of last year, rn was taking care of patient with crrt prismaflex running continuously. There were reported "access pressures" issues with the patient and all possible nursing interventions were carried out to attempt to correct problem. The nurse then reported that the machine alarmed with a malfunction of the effluent scale. The machine shut itself down and would not allow any retesting to occur. The machine was sent to biomed for inspection and a replacement prismaflex machine was brought in to continue with the ordered therapy. ====================== manufacturer response for hemodialysis unit, prismaflex machine======================gambro assisted with testing on site and serviced the device at their location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1291143 |
| MDR Report Key | 1291143 |
| Date Received | 2009-01-03 |
| Date of Report | 2009-01-03 |
| Date of Event | 2008-07-12 |
| Report Date | 2009-01-03 |
| Date Reported to FDA | 2009-01-03 |
| Date Added to Maude | 2009-01-22 |
| 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 |
| 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 MACHINE, CRRT/CVVH |
| Product Code | MQS |
| Date Received | 2009-01-03 |
| Returned To Mfg | 2008-07-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC. |
| Manufacturer Address | 10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-03 |