MalfunctionFII
9 LITER ACCESSORY DRAIN BAG (1 SP-418)
Received Feb 7, 2010 · Event occurred Dec 21, 2009
Report 1601433 · MDR key 1601433
Device
Generic name
Bag, Drainage, Crrt
Manufacturer
Gambro Renal ProductsModel number
NACatalog number
6033765
Lot number
NA
Product problems
- Burst Container or Vessel
- Fluid/Blood Leak
Patient
3 MO
- No Information
Narrative
Description of Event or Problem
NINE LITER EFFLUENT (DRAINAGE BAG) SUDDENLY BURST OPEN AT SIDE SEAM AND GUSHED EFFLUENT DRAINAGE ALL OVER THE FLOOR, MACHINE ETC. THIS IS SECOND BAG IN ONE WEEK. THE OTHER BAG HAD LEAKED AT THE MID CIRCLE SEAM. WE ARE TRYING TO DETERMINE IF BAG IS TOO FULL AS BOTH OCCURRED AT ABOUT THE FULL POINT.