MalfunctionFII
9 LITER ACCESSORY DRAIN BAG (1 SP-418)
Received Feb 7, 2010 · Event occurred Dec 21, 2009
Report 1601429 · MDR key 1601429
Device
Generic name
Bag, Drainage, Crrt
Manufacturer
Gambro Renal ProductsModel number
NACatalog number
6033765
Lot number
NA
Product problems
- Fluid/Blood Leak
- Material Rupture
Patient
3 MO
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
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.