MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-04 for M100 PRISMAFLEX FILTER * manufactured by Gambro Renal Products, Inc.
[19246983]
The filter separated from the return line tubing that was exiting from the top of the filter. The new filter and tubing were obtained. The tubing with the filter was being set up and had not been in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1716922 |
| MDR Report Key | 1716922 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-06-04 |
| Date of Event | 2010-05-27 |
| Report Date | 2010-06-04 |
| Date Reported to FDA | 2010-06-04 |
| Date Added to Maude | 2010-06-10 |
| 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 | M100 PRISMAFLEX FILTER |
| Generic Name | CRRT FILTER |
| Product Code | MQS |
| Date Received | 2010-06-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 10B1988PG |
| ID Number | * |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS, INC |
| Manufacturer Address | 14143 DENVER WEST PARKWAY LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-04 |