MalfunctionFII
*
Received Dec 13, 2009 · Event occurred Nov 7, 2009
Report 1560508 · MDR key 1560508
Device
Generic name
Effluent Bag, Drainage
Manufacturer
Gambro Renal Products, Inc.Model number
*Catalog number
6033765
Lot number
0806791
Product problems
- Burst Container or Vessel
- Fluid/Blood Leak
- Hole In Material
Patient
6 YR
- No Information
Narrative
Description of Event or Problem
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.