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..
[16731038]
During priming of routine change of prismaflex tubing there was a "pinch valve" malfunction alarm. The help screens for that alarm did not give any real troubleshooting directions. The 800 number was called for company assistance. Unloading and reloading with a lot of other steps were involved. We finally did get the circuit primed. We basically had to start over with threading and priming. Three staff members spent several hours troubleshooting. There was an extended period of time that the patient was off machine during new circuit prime. The patient had fluid bolus and we were unable to make up for the fluid given while the circuit was off.
Patient Sequence No: 1, Text Type: D, B5
[16836276]
During priming of routine change of prismaflex tubing there was a "pinch valve" malfunction alarm. The help screens for that alarm did not give any real troubleshooting directions. The 800 number was called for company assistance. Unloading and reloading with a lot of other steps were involved. We finally did get the circuit primed. We basically had to start over with threading and priming. Three staff members spent several hours troubleshooting. There was an extended period of time that the patient was off machine during new circuit prime. The patient had fluid bolus and we were unable to make up for the fluid given while the circuit was off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526000 |
| MDR Report Key | 1526000 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-10-03 |
| Date of Event | 2009-10-03 |
| Report Date | 2009-10-03 |
| 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 |