HEART-LUNG MACHINE HL20
Received Aug 3, 2015 · Event occurred Jul 24, 2015
Report 8010762-2015-00866 · MDR key 4972743
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A FIELD SAFETY TECHNICIAN OPENED THE RPM AND ONE BELT IS BROKEN (THE SECOND ONE SEEMS TO BE OK). HE MEASURED THE BELT TENSION 445 HZ. POSSIBLE ROOT CAUSE: DEFECTIVE BELT FROM A FACTORY, TENSION TOO HIGH, MAYBE COMBINATION OF BOTH. HE REPAIRED (BELT REPLACEMENT) / ORDERING NEW MOTOR ISOLATION KIT FOR BETTER ADJUSTMENT OF TENSION. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE SURGERY, THE RPM MODULE REPORTED AN ERROR "BELT SLIP". THE PERFUSIONIST STOPPED THE PUMP BUT THE ERROR WAS STILL THERE. SO THEY STOPPED THE "SUCTION" FUNCTION. (B)(4).