VIRAJECT DIALYSIS TRANSDUCER PROTECTOR
Received Nov 29, 1994
Report MW1004175 · MDR key 18023
Device
Manufacturer
Terumo Medical Corp.Lot number
1134
Product problems
- Leak/Splash
Patient
36 YR
Narrative
Description of Event or Problem
THE DEVICE LEAKED. THE DEVICE WAS FILLED WITH BLOOD AND HAD TO BE CHANGED SEVERAL TIMES DURING TREATMENT RESULTING IN CLOTTING OF THE DIALYZER AND LOSS OF APPROX 100 CC OF BLOOD. BLOOD ALSO LEAKED THROUGH THE DEVICE INTO THE PRESSURE TRANSDUCER WHICH HAD TO BE DISASSEMBLED, CLEANED AND DISINFECTED.