BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HL-20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 4283351 · Received November 28, 2014

    Report

    Report Number
    8010762-2014-00553
    Event Type
    Injury
    Date Received
    November 28, 2014
    Date of Event
    November 24, 2011
    Report Date
    November 25, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE, MAQUET CARDIOPULMONARY (B)(4). THE ROTAFLOW WAS TAKEN OUT OF SERVICE BUT THE HL20 REMAINED IN SERVICE. ROTAFLOW CONSOLE (RFC) SERIAL NUMBER (B)(4) WAS RETURNED TO MAQUET (B)(4) (MANUFACTURER) FOR FURTHER EVALUATION. A REQUEST ANALYSIS REPORT WAS STARTED ON (B)(4) 2012 FOR THE EVALUATION OF THE UNIT. PER THE REQUEST ANALYSIS REPORT, THE RFC WAS SET-UP AND OPERATED WITH TWO DIFFERENT HL20 CONSOLE, FOR (B)(4) PER HL20 CONSOLE. THE RFC WAS OPERATED IN ARTERIAL MODE ON BOTH HL 20 CONSOLES. DURING THE TESTING PERIOD, THE REVOLUTIONS PER MINUTES (RPM) WAS CHANGED SEVERAL TIMES A DAY ((B)(4)) BETWEEN 500 AND 4000 RPMS. NO COMMUNICATION ERROR OCCURRED DURING THE TWO WEEKS OF TESTING. THEREFORE, IT WAS CONCLUDED THAT THE ERROR COULD NOT BE REPRODUCED AND THE RFC COULD BE RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, AT (B)(6), A "NO COMMUNICATION" ERROR WAS RECEIVED ON A ROTAFLOW CONSOLE SERIAL NUMBER (B)(4). THIS ERROR CAUSED THE ROTAFLOW TO SHUTDOWN WHILE IN ARTERIAL MODE. AT THE TIME OF THE EVENT, THE ROTAFLOW CONSOLE WAS IN-USE WITH HL20 SERIAL NUMBER (B)(4). THE ROTAFLOW WAS TAKEN OUT OF SERVICE BUT THE HL20 REMAINED IN SERVICE. NOTE: AN ADDITIONAL COMPLAINT (B)(4) WAS OPENED FOR THIS EVENT. COMPLAINT (B)(4), MFR REPORT # 8010762-2014-00557; THIS REPORT WILL BE SUBMITTED FOR THE ROTAFLOW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771545 HL-20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART/LUNG MACHINE DTQ MAQUET CARDIOPULMONARY AG 70102.8583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention