BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 8015 PCU POINT OF CARE UNIT INFUSION PUMP 5.7" SCREEN

    MDR report key: 12102070 · Received July 1, 2021

    Report

    Report Number
    3007409280-2021-00008
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS HEATING UP. THE BIOMED NOTICED THE UNIT HEATING UP NEAR THE ALUMINUM MOUNTING BRACKET AFTER BEING PLUGGED IN FOR A PROLONGED AMOUNT OF TIME. HE BELIEVES THE ISSUE IS NOT WITH THE BATTERY; RATHER, THE POWER SUPPLY BOARD. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. TECHNICAL EVALUATION IDENTIFIED A BOARD MALFUNCTION; SPECIFICALLY, A DEFECTIVE SUPPLY POWER BOARD THAT WAS GETTING HOT. ADDITIONALLY, THE KEYPAD WAS SEPARATING FROM THE FRONT BEZEL. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THE KEYPAD ADHESIVE WAS COMING UNDONE. THE 24V POWER SUPPLY AND THE POWER SUPPLY PCBA WERE REPLACED. THE DEVICE WAS REPAIRED AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF SERVICE AND TESTING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    THE DEVICE WAS HEATING UP. THE BIOMED NOTICED THE UNIT HEATING UP NEAR THE ALUMINUM MOUNTING BRACKET AFTER BEING PLUGGED IN FOR A PROLONGED AMOUNT OF TIME. HE BELIEVES THE ISSUE IS NOT WITH THE BATTERY; RATHER, THE POWER SUPPLY BOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001808 ALARIS 8015 PCU POINT OF CARE UNIT INFUSION PUMP 5.7" SCREEN ALARIS PC UNIT, MODELS 8000 AND 8015 FRN CARDINAL HEALTH 303, INC. FIAL2016

    Patients

    Seq Age Sex Outcome Treatment
    1