Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED: PUMP FOUND IN OFFICE WITH CARTRIDGE ERROR REPORTED, DID HARD SHUT DOWN, RAN TEST INFUSION, ADMIN SET ERROR APPEARED ON SCREEN, I CLEARED ERROR AND IT DID NOT RETURN. DID NOT DOWNLOAD LOGS. A REVIEW OF THE LOGS HAS ALLOWED FRESENIUS KABI ENGINEERING TO REVIEW AND IDENTIFY THE FOLLOWING ISSUE: INLET VALVE ACTUATOR-IMPROPER MOVEMENT COMMAND REPORTING DUE TO REFERENCED ISSUE. NO ADVERSE EFFECTS WERE REPORTED. THE DEVICE WAS RECEIVED BACK FOR INVESTIGATION. FLUID VALVE ASSEMBLY WAS UNABLE TO OPERATE AS INTENDED DURING STARTUP CHECK, CAUSING A PUMP PROBLEM ALARM TO BE RAISED. INTERMITTENT OPERATION OF THE FLUID VALVE ACTUATOR. EACH OF THE VALVES ARE MONITORED BY SENSORS TO VERIFY THAT THEY HAVE BEEN PULLED TO THE CORRECT OPEN POSITION. THE PUMP CORRECTLY IDENTIFIED THIS INABILITY, AND ALARMED AS EXPECTED. CONCLUSION: FVA PINS WERE NOT ABLE TO REACH THEIR TARGET DESTINATIONS DURING OPERATION DUE TO TORQUE LOSSES IN THE SYSTEM. ROOT CAUSE: INCORRECTLY INSTALLED WAVE SPRING (55-1595) IN FVA ASSEMBLY 20-0032. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR SUBMISSION AS A CONSERVATIVE MEASURE.