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..
[1248778]
There was a malfunction of the prismaflex. The machine was restarted twice. Reviewed alarms and took steps per rep's guidance through gambro's help line to resolve. Staff unable to clear alarm that pre-blood pump scale component missing. The machine was running with yellow light. Gambro's recommendation was to end treatment, flush blood back to patient, and disconnect due to machine malfunction of scale. A different machine was acquired and now running without difficulty.
Patient Sequence No: 1, Text Type: D, B5
[1326965]
There was a malfunction of the prismaflex. The machine was restarted twice. Reviewed alarms and took steps per rep's guidance through gambro's help line to resolve. Staff unable to clear alarm that pre-blood pump scale component missing. The machine was running with yellow light. Gambro's recommendation was to end treatment, flush blood back to patient, and disconnect due to machine malfunction of scale. A different machine was acquired and now running without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526354 |
| MDR Report Key | 1526354 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-08-25 |
| 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 |