MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-12 for 9 LITER DRAINAGE BAG * SP-418 (9L BAG) manufactured by Gambro Renal Products, Inc..
[16416372]
Prismaflex ultrafiltrate drainage bag hanging on hooks to be drained. Nine liter bag attached to drainage tubing and had just begun draining when it burst open on one side toward center. The hole was approximately four centimeters round. The ultrafiltrate was spraying with great force out of the bag onto dialysis tubing, iv pumps, tubing, and the floor. The hanging bag was grabbed and thrown into the sink by the toilet and bath blankets were thrown onto the floor to absorb the fluid. Housekeeping mopped three times. Iv pumps and tubing was sprayed down with virex spray, as well as this nurse's shoes, which will have to be thrown away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1560506 |
| MDR Report Key | 1560506 |
| Date Received | 2009-12-12 |
| Date of Report | 2009-12-12 |
| Date of Event | 2009-10-19 |
| Report Date | 2009-12-12 |
| Date Reported to FDA | 2009-12-12 |
| Date Added to Maude | 2009-12-16 |
| 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 | 9 LITER DRAINAGE BAG |
| Generic Name | EFFLUENT, DRAINAGE BAG |
| Product Code | FII |
| Date Received | 2009-12-12 |
| Returned To Mfg | 2009-11-11 |
| Model Number | * |
| Catalog Number | SP-418 (9L BAG) |
| Lot Number | 0921 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| 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 |