MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-10 for PRISMAFLEX NA manufactured by Gambro Renal Products, Inc.
[1095149]
Patient receiving cvvhd and the machine alarmed. Malfunction: scales circuit board alarm. Contacted 1-800 support line who stated it was a technical problem with the machine. The only option was to manually return the blood. The blood was starting to separate in the tubing and i did not want to risk returning clots. The patient was unaffected, and sitting up at the bedside after disconnection. Gambro tested the device but could not duplicate the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1444558 |
| MDR Report Key | 1444558 |
| Date Received | 2009-08-10 |
| Date of Report | 2009-08-07 |
| Date of Event | 2009-07-07 |
| Report Date | 2009-08-07 |
| Date Reported to FDA | 2009-08-10 |
| Date Added to Maude | 2009-08-20 |
| 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 | 3 |
| 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, CVVHD |
| Product Code | MQS |
| Date Received | 2009-08-10 |
| Model Number | PRISMAFLEX |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 MO |
| 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 | 2009-08-10 |