MalfunctionFEN
ABVISER AUTOVALVE
Received Nov 14, 2018 · Event occurred Apr 5, 2018
Report 8068606 · MDR key 8068606
Device
Product problems
- Defective Component
Patient
25550 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
BLADDER PRESSURE MONITORING DEVICE IN USE. 40CC INTRAVASCULAR FLUID (IVF) INSTILLED AND DEVICE CONTROLLED TO RELEASE FLUID AFTER 2-3 MINUTES. PATIENT WITH NO URINARY OUTPUT FOR SEVERAL HOURS DESPITE BLADDER PRESSURE MONITORING AND INSTILLED IVF INTO BLADDER. REMOVED DEVICE, 70CC URINE DRAINED FROM BLADDER. DEVICE MALFUNCTIONED AND WAS NOT RELEASING URINE OR FLUID. NO PATIENT HARM OR CHANGE IN CARE DUE TO MALFUNCTION. NO MODEL NUMBER OR SERIAL NUMBER ON DEVICE AS CONTAINER WAS THROWN AWAY UPON INITIATION. DEVICE NOT AVAILABLE FOR RETURN.