MalfunctionFIB
NIPRO SET BLOOD TUBING SET FOR HEMODIALYSIS
Received May 22, 2006 · Event occurred May 3, 2006
Report 1056186-2006-00008 · MDR key 720831
Device
Generic name
Blood Tubing Line
Manufacturer
Nipro Medical CorporationModel number
A217/V806Catalog number
A217/V806
Lot number
05L25
Product problems
- Device Alarm System
- Fluid/Blood Leak
Patient
UNKNOWN
- Blood Loss
Narrative
Description of Event or Problem
APPROX 1 HOUR INTO DIALYSIS TREATMENT, BLOOD WAS NOTICED LEAKING FROM THE BLOOD PUMP SEGMENT AREA. THERE WAS MINIMAL BLOOD LOSS AND NO HARM WAS DONE TO THE PT.
Remedial action
- Inspection