MalfunctionBTC
NL 8500-500V
Received Apr 15, 2003 · Event occurred Mar 13, 2003
Report 456034 · MDR key 456034
Device
Generic name
Drainage Bag System
Manufacturer
Integra NeurosciencesModel number
INS5010Catalog number
INS5010
Lot number
*
Product problems
- Fail-Safe Design Failure
- Fluid/Blood Leak
Patient
34 YR
- Cerebrospinal Fluid Leakage
Narrative
Description of Event or Problem
THE SHUT-OFF VALVE ON LUMBAR DRAINAGE SYSTEM DID NOT TURN OFF, RESULTING IN OVER DRAINAGE OF CSF, EVEN THOUGH ALL OF THE VALVES ON THE EQUIPMENT WERE CLAMPED.