9 LITER DRAINAGE BAG
Received Dec 12, 2009 · Event occurred Oct 19, 2009
Report 1560506 · MDR key 1560506
Device
Generic name
Effluent, Drainage Bag
Manufacturer
Gambro Renal Products, Inc.Model number
*Catalog number
SP-418 (9L BAG)
Lot number
0921
Product problems
- Burst Container or Vessel
- Fluid/Blood Leak
- Hole In Material
Patient
30 YR
- Exposure to Body Fluids
Narrative
Description of Event or Problem
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.