inforMED

VIRAJECT DIALYSIS TRANSDUCER PROTECTOR

Received Nov 29, 1994

Report MW1004175 · MDR key 18023

Device

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.