BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 2974041 · Received February 19, 2013

    Report

    Report Number
    8010762-2013-00011
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A FIELD SERVICE TECHNICIAN HAS DISASSEMBLED THE PUMP MODULE AND FOUND NO MECHANICAL OR ELECTRICAL ISSUES. NO ABNORMALITIES HAVE BEEN FOUND WITH THE ODU CONNECTORS AND THE RESISTANCE OF SOME ELECTRICAL COMPONENTS. THE REPORTED PUMP MODULE HAS BEEN POSITIONED TO AN NON CRUCIAL POSITION ON THE CONSOLE. ANOTHER PUMP HAS BEEN SWAPPED INTO THE ARTERIAL POSITION INSTEAD. THE CUSTOMER HAS RECEIVED A LOANER UNIT. THE DEVICE HAS BEEN RETURNED FOR INSPECTION AT THE MANUFACTURER FACILITY. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    DURING EXTRACORPOREAL CIRCULATION THE ARTERIAL PUMP OF THE HEART-LUNG-MACHINE HL 20 STOPPED ROTATING. THERE WERE NO ALARMS FOR BUBBLE, LEVEL OR PRESSURE. THE PERFUSIONIST TRIED TO RESTART THE PUMP MODULE USING THE ON/OFF SWITCH TWICE. AFTER THIS FAILED HE COMMENCED TO USE THE EMERGENCY HAND CRANK AS DESCRIBED IN THE USER MANUAL. THE PERFUSIONIST TURNED THE HAND CRANK VERY QUICKLY IN AN EFFORT TO INDUCE AN ALARM. AT THIS POINT, THE PUMP STARTED TO ROTATE. THE CASE WAS COMPLETED SUCCESSFULLY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72558 MAQUET CARDIOPULMONARY AG HL 20 5-PUMPS ONCSOLE BASE DTQ MAQUET CARDIOPULMONARY AG 70102.8581

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention