BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 21857751 · Received April 17, 2025

    Report

    Report Number
    3010532612-2025-00318
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 25, 2025
    Report Date
    March 25, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). RETURNED FOR INVESTIGATION WAS A PCS ASSEMBLY. THE SAMPLE WAS RETURNED IN A BROWN CARDBOARD BOX WITH PROTECTIVE SHIPPING PACKAGING. VISUAL INSPECTION OF THE PCS ASSEMBLY WAS PERFORMED, AND NO ABNORMALITY WAS NOTED. ALL VALVES WERE INDIVIDUALLY TESTED BY POWERING THEM ON AND OFF USING AN EX-TERNAL 12V DC POWER SUPPLY. EACH VALVE RESPONDED PROPERLY TO THE 12V SUPPLIED WITH AN AUDIBLE CLICK, INDICATING PROPER VALVE FUNCTION WITH NO STUCK VALVES. THE PCS ASSEMBLY WAS INSTALLED INTO A KNOWN GOOD LAB INVENTORY AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED ON, AND PUMPING WAS INITIATED. THE LEAK TEST WAS PERFORMED; IT PASSED BOTH THE SOURCE SIDE AND PATIENT SIDE LEAK TESTS. THE PUMP WAS THEN LEFT TO RUN FOR OVER AN HOUR AND NO LEAKS OR ALARMS WERE NOTED. THE PCS ASSEMBLY FUNCTIONED AS INTENDED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT OF PURGE FAILURE ALARM WAS CONFIRMED BY THE FIELD SERVICE AGENT; HOWEVER, THE RETURNED PCS ASSEMBLY PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS DURING COMPLAINT INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PUMP HAD 'PURGE ALARM' WHEN ATTEMPTING TO START COUNTERPULSATION ON PATIENT. PUMP WAS SWITCHED OUT AND REPLACEMENT PUMP HAD NO ISSUES". "NO PATIENT HARM" REPORTED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "PUMP HAD 'PURGE ALARM' WHEN ATTEMPTING TO START COUNTERPULSATION ON PATIENT. PUMP WAS SWITCHED OUT AND REPLACEMENT PUMP HAD NO ISSUES". "NO PATIENT HARM" REPORTED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775746 ARROW AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown