MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-08 for PRISMAFLEX HF 1400 CIRCUIT * manufactured by Gambro Renal Products, Inc..
[1120389]
Prismaflex circuit changed on evening shift due to 96 hour limit. New circuit had to be replaced at midnight due to inability to recover from pressure alarms. This circuit started without incident. An extra manual prime was done. Large amount of foam developed in the deaeration chamber, which was removed multiple times with syringe. The foam continuously reaccumulated, and it appeared to be from the purple line initially where it enters the deaeration chamber. It was later noted that small bubbles were at the top of the filter in the blood line when the blood was being returned. All connections were checked and double checked. Attempted to change the rate of the post replacement fluid. This did not change the rate of foam accumulation. A new circuit was then started with a full re-prime of the circuit. There were no issues with this circuit.
Patient Sequence No: 1, Text Type: D, B5
[1302809]
Prismaflex circuit changed on evening shift due to 96 hour limit. New circuit had to be replaced at midnight due to inability to recover from pressure alarms. This circuit started without incident. An extra manual prime was done. Large amount of foam developed in the deaeration chamber, which was removed multiple times with syringe. The foam continuously reaccumulated, and it appeared to be from the purple line initially where it enters the deaeration chamber. It was later noted that small bubbles were at the top of the filter in the blood line when the blood was being returned. All connections were checked and double checked. Attempted to change the rate of the post replacement fluid. This did not change the rate of foam accumulation. A new circuit was then started with a full re-prime of the circuit. There were no issues with this circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525998 |
| MDR Report Key | 1525998 |
| Date Received | 2009-11-08 |
| Date of Report | 2009-11-08 |
| Date of Event | 2009-10-17 |
| 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 HF 1400 CIRCUIT |
| Generic Name | HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPY TUBING |
| Product Code | MQS |
| Date Received | 2009-11-08 |
| Model Number | * |
| Catalog Number | PRISMAFLEX HF 1400 CIRCUIT |
| Lot Number | 8399040 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| 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 |