BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HL-20 TWIN PUMP

    MDR report key: 4280410 · Received November 26, 2014

    Report

    Report Number
    8010762-2014-00504
    Event Type
    Malfunction
    Date Received
    November 26, 2014
    Date of Event
    August 18, 2011
    Report Date
    September 2, 2011
    Manufacturer
    MAQUET CARDIOPULMOARY AG
    Product Code
    DPW
    PMA / PMN Number
    984338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SAFETY ENGINEER (FSE) PERFORMED THE UPDATE MCV/011/0002/IU ON 2 TPMS. THE FSE UPDATED SOFTWARE VERSION 1.4 TO VERSION 2.5. BASED UPON COMMUNICATION WITH THE SERVICE DEPARTMENT, THE VERSION 2.5 SOFTWARE WAS ONLY FOR RELEASE 11 TPMS, THE TPMS INVOLVED IN THIS EVENT WERE RELEASE 10. THE FSE WAS INSTRUCTED TO REINSTALL THE OLD, VERSION 1.4 SOFTWARE ON THE TPMS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, AT (B)(6), AN "ARTERIAL STOP" ERROR WAS RECEIVED ON TWIN PUMP MODULE (TPM) EN MED C (ARTICLE NUMBER: (B)(4)) WHILE BEING USED WITH HL20 5 PUMP CONSOLE ((B)(4)) THE ARTERIAL PUMP WORKS PROPERLY (E.G. 100 ROTATIONS/MIN), HOWEVER, THE CARDIOPLEGIA PUMP (IN SLAVE MODE) TURNS A QUARTER OF TURN, THEN STOPS, THEN TURNS A HALF A TURN, THEN STOPS, AND SO ON. THIS PROBLEM WAS OBSERVED AFTER THE FIELD SERVICE ENGINEER PERFORMED A SOFTWARE UPDATE ON THE TPM FROM VERSION 1.4 TO NEW SOFTWARE VERSION 2.5. A SECOND MDR WILL BE GENERATED FOR THIS EVENT SINCE TWO TWIN PUMP MODULE AND CONSOLE SERIAL NUMBERS ARE LISTED IN THE COMPLAINT. THE SECOND MDR # IS 8010762-2014-01077. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768346 MAQUET HL-20 TWIN PUMP FLOWMETER, BLOOD, CARDIOVASCULAR DPW MAQUET CARDIOPULMOARY AG MCP00703277

    Patients

    Seq Age Sex Outcome Treatment
    1