MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-13 for * 6033765 manufactured by Gambro Renal Products, Inc..
[1449110]
Continous renal replacement therapy (crrt)treatment proceeding when bag spontaneously burst a hole in the center of bag. Effluent was coming out of the bag onto the floor.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1560508 |
MDR Report Key | 1560508 |
Date Received | 2009-12-13 |
Date of Report | 2009-12-13 |
Date of Event | 2009-11-07 |
Report Date | 2009-12-13 |
Date Reported to FDA | 2009-12-13 |
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 | 0 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | * |
Generic Name | EFFLUENT BAG, DRAINAGE |
Product Code | FII |
Date Received | 2009-12-13 |
Returned To Mfg | 2009-12-09 |
Model Number | * |
Catalog Number | 6033765 |
Lot Number | 0806791 |
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 | 2009-12-13 |