MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-07 for 9 LITER ACCESSORY DRAIN BAG (1 SP-418) 6033765 manufactured by Gambro Renal Products.
[20933405]
Patient on crrt (continuous renal replacement therapy)with nine liter effluent bag in use. The effluent bag spontaneously ruptured at seams spilling large volume of effluent on the floor, nurse, and equipment. The bag was immediately changed. There was no adverse effect to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1601429 |
| MDR Report Key | 1601429 |
| Date Received | 2010-02-07 |
| Date of Report | 2010-02-07 |
| Date of Event | 2009-12-21 |
| Report Date | 2010-02-07 |
| Date Reported to FDA | 2010-02-07 |
| Date Added to Maude | 2010-02-17 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9 LITER ACCESSORY DRAIN BAG (1 SP-418) |
| Generic Name | BAG, DRAINAGE, CRRT |
| Product Code | FII |
| Date Received | 2010-02-07 |
| Returned To Mfg | 2010-01-06 |
| Model Number | NA |
| Catalog Number | 6033765 |
| Lot Number | NA |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO RENAL PRODUCTS |
| Manufacturer Address | 14143 DENVER WEST PARKWAY SUIT LAKEWOOD CO 80401 US 80401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-07 |