MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-12 for * PRISMAFLEX manufactured by Gambro Renal Products, Inc..
[1455769]
Patient on continuous renal replacement therapy (crrt) had several incidents of "negative access pressure" with patient coughing, moving, etc. Rn had been able to relieve vacuum built up and recover several times. This time she was unable to correct the alarm and the machine said "system clotted". Returned blood and discovered that there was no clotting in the circuit after all. Unloaded and reloaded set, and reprimed to hook back up to patient. Partway thru prime got "pinch valve malfunction" alarm. Had to unload and reload, and restart machine and prime. Able to reprime circuit and hook back up to patient, but patient was off crrt several hours. Four rn's at bedside troubleshooting the system (included one crrt orientee).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1567114 |
| MDR Report Key | 1567114 |
| Date Received | 2009-12-12 |
| Date of Report | 2009-12-12 |
| Date of Event | 2009-10-05 |
| Report Date | 2009-12-12 |
| Date Reported to FDA | 2009-12-12 |
| Date Added to Maude | 2009-12-30 |
| 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 | * |
| Generic Name | HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPY |
| Product Code | FII |
| Date Received | 2009-12-12 |
| 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 | 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-12 |