BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AC3 OPTIMUS IABP NA/EMEA

    MDR report key: 25221011 · Received May 19, 2026

    Report

    Report Number
    3010532612-2026-00512
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 22, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    PMA / PMN Number
    K162820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETURNED FOR INVESTIGATION WERE THE AC3 CPM BOARD (P/N: 33-1000-004, S/N: (B)(6), AND THE AC3 DISPLAY HEAD (P/N 33-0100-003, S/N: (B)(6). THE SAMPLES WERE RETURNED IN THE WHITE SHIPPING BOX, PROTECTED BY PROTECTIVE SHIPPING PACKAGING, AND THE CPM BOARD WAS FURTHER ENCLOSED IN AN ELECTROSTATIC PROTECTIVE BAG. VISUAL INSPECTION OF THE RETURNED SAMPLES WAS PERFORMED AND NO ABNORMALITY WAS NOTED. THE DISPLAY HEAD WAS INSTALLED ONTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. THE PUMP WAS POWERED UP SUCCESSFULLY, AND NO ABNORMALITIES WERE NOTED ON THE SCREEN. THE SYSTEM HAD A NORMAL RESPONSE TO THE HARD KEYS. PUMPING WAS INITIATED. EACH HARD KEY WAS PRESSED MULTIPLE TIMES AND THE SYSTEM PROPERLY RESPONDED TO EACH PRESS. NO SYSTEM ERROR 7 ALARM WAS NOTED. ALL THE WAVEFORMS AND ICONS DISPLAYED CORRECTLY. A HIGH PRIORITY ALARM WAS PURPOSELY GENERATED AND THE PUMP HAD A PROPER RESPONSE BY FREEZING THE DISPLAY WHICH WAS ABLE TO BE UNFROZEN USING THE TOUCH SCREEN. THE CORNER SWITCH PROPERLY ILLUMINATED AND RESPONDED TO EACH PRESS. THE PUMP WAS LE FT TO RUN FOR OVER 1 HOUR WITH NO ISSUES OR ALARMS. THE CPM BOARD WAS INSTALLED INTO A KNOWN GOOD AC3 FOR FUNCTIONAL TESTING. ALL VOLTAGES WERE WITHIN SPECIFICATION. UPON POWER UP, THE SCREEN BEGAN BRIGHTENING AND BECAME COVERED IN VERTICAL AND HORIZONTAL LINES ALONG THE PIEZO ALARM. THE SYSTEM AND SCREEN THEN UNDERWENT A REBOOT CYCLE. FOLLOWING THE PUMP REBOOT CYCLE, THE SYSTEM REPEATED THE SAME DISPLAY ISSUE WHILE THE PIEZO ALARM WAS STILL SOUNDING. THE SYSTEM AND SCREEN CONTINUED THIS CYCLE BEFORE BEING TURNED OFF. 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. CORRECTIVE ACTION IS NOT REQUIRED. THE REPORTED COMPLAINT FOR "SCREEN MALFUNCTION" IS CONFIRMED. DURING THE COMPLAINT INVESTIGATION, THE RETURNED CPM WAS FOUND TO UNDERGO A REBOOT CYCLE UPON STARTING THE PUMP POWER CYCLE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE REBOOTING DISPLAY SCREEN. THE ROOT CAUSE OF THIS COMPLAINT IS UNDETERMINED. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "STAFF REPORTED A 'SCREEN MALFUNCTION' ON A PATIENT". AS A RESULT THE PUMP WAS EXCHANGED FOR ANOTHER PUMP. NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514726 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 N/A.