BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 17240192 · Received June 30, 2023

    Report

    Report Number
    3010532612-2023-00364
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 6, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902172065
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED FOR INVESTIGATION WERE A MARTEK POWER SUPPLY (P/N: 77-0063-003, S/N: 0590-1519) AND A BATTERY (P/N: 4000-9022-001, L/N: 18F23A0001). THE SAMPLES WERE RETURNED IN A BROWN CARDBOARD BOX WITH PROTECTIVE SHIPPING PACKAGING. VISUAL INSPECTION OF THE POWER SUPPLY AND BATTERY WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE BATTERY AND POWER SUPPLY WERE INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE IABP POWERED UP SUCCESSFULLY WITH NO ALARM, ALL VOLTAGES WERE PRESENT (+5V, +12V AND -12V) AND WITHIN SPECIFICATIONS. THE BATTERY LOAD TEST WAS PERFORMED. THE IABP WAS RUN ON BATTERY UNTIL THE IABP SHUT DOWN. THE BATTERIES WERE THEN LEFT TO CHARGE IN THE IABP FOR OVER 9 HOURS. THE FULL CHARGE OF BATTERIES WAS 13.1 VOLTS. PUMPING WAS INITIATED. THE IABP GAVE A PROPER ALARM WHEN DISCONNECTED FROM THE AC POWER. THE IABP ALARMED "LESS THAN 20 MINUTES REMAINING" AFTER APPROXIMATELY 59 MINUTES WHEN RUNNING ON BATTERY POWER. THE IABP ALARMED "LESS THAN 10 MINUTES REMAINING" AFTER APPROXIMATELY 81 MINUTES WHEN RUNNING ON BATTERY POWER. THE IABP ALARMED "LESS THAN 5 MINUTES REMAINING" AFTER APPROXIMATELY 91 MINUTES WHEN RUNNING ON BATTERY POWER. THE TOTAL BATTERY RUNTIME WAS APPROXIMATELY 113 MINUTES. THE PUMP PASSED THE BATTERY LOAD TEST. THE IABP WAS THEN PLUGGED INTO AC POWER TO SIMULATE AN ENDURANCE TEST. THE IABP WAS LEFT RUNNING FOR OVER 24 HOURS WITH NO ALARMS OR ERRORS. NOTE: PER OPERATOR'S MANUAL "THE BATTERY SHOULD BE MAINTAINED AT FULL CHARGE WHENEVER POSSIBLE. ARROW INTERNATIONAL RECOMMENDS THAT THE AC2 BE KEPT PLUGGED INTO A PROPER AC RECEPTACLE WHENEVER POSSIBLE INCLUDING TIME WHEN THE UNIT IS IN STORAGE OR NOT IN USE. THE POWER INDICATOR WILL ILLUMINATE WHEN AC POWER IS PRESENT. THE BATTERIES SHOULD NOT BE STORED IN A DISCHARGED STATE." A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBERS WITH 4 RELEVANT FINDINGS; HOWEVER, THE AFFECTED POWER SUPPLIES WERE RETURNED TO THE VENDOR. THE REPORTED COMPLAINT OF THE PUMP SHUT OFF WHILE ON A PATIENT IS NOT CONFIRMED. THE RETURNED BATTERY AND POWER SUPPLY PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH 4 RELEVANT FINDINGS; HOWEVER, THE AFFECTED POWER SUPPLIES WERE RETURNED TO THE VENDOR. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "IABP HAS SHUT OFF A COUPLE TIMES WHILE ON A PATIENT. THE REGISTERED NURSE RN WAS ABLE TO RESTART THE IABP BY SWITCHING THE ON/OFF SWITCH OFF,THEN BACK ON. THE WHOLE CONSOLE WAS SHUTTING DOWN WITH NO WARNING. THIS MORNING WE SWAPPED OUT THE CONSOLE WITH A NEW ONE SO WE COULD BRING THE AFFECTED UNIT TO CE. THERE DIDN'T SEEM TO BE ANY INSTIGATING FACTOR CAUSING THE IABP TO SHUT DOWN." ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO IMPACT, HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "RECEIVED A HEART TRANSPLANT THE NEXT DAY AND IS NO LONGER ON IABP SUPPORT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "IABP HAS SHUT OFF A COUPLE TIMES WHILE ON A PATIENT. [THE RN] WAS ABLE TO RESTART THE IABP BY SWITCHING THE ON/OFF SWITCH OFF, THEN BACK ON. THE WHOLE CONSOLE WAS SHUTTING DOWN WITH NO WARNING. THIS MORNING WE SWAPPED OUT THE CONSOLE WITH A NEW ONE SO WE COULD BRING THE AFFECTED UNIT TO CE. THERE DIDN'T SEEM TO BE ANY INSTIGATING FACTOR CAUSING THE IABP TO SHUT DOWN." ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO IMPACT, HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "RECEIVED A HEART TRANSPLANT THE NEXT DAY AND IS NO LONGER ON IABP SUPPORT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343838 AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN917285 N/A 10801902172065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown