MalfunctionFII
*
Received Dec 13, 2009 · Event occurred Nov 20, 2009
Report 1560544 · MDR key 1560544
Device
Generic name
Effluent Bag, Drainage
Manufacturer
Gambro Renal Products, Inc.Model number
*Catalog number
6033765
Lot number
0923
Product problems
- Burst Container or Vessel
- Fluid/Blood Leak
Patient
31 YR
- No Information
Narrative
Description of Event or Problem
CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) DRAIN BAG BURST OPEN IN CENTER AT SITE OF "BUTTON". APPROXIMATELY, EIGHT LITERS OF ULTRAFILTRATE EXPLODED ON THE FLOOR AND EQUIPMENT. NO MALFUNCTION OF EQUIPMENT OCCURRED. DRAIN BAG WAS REPLACED AND CRRT CONTINUED TO RUN.