BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4285645 · Received December 1, 2014

    Report

    Report Number
    8010762-2014-00557
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    November 24, 2011
    Report Date
    November 25, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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 06/04/2012 FOR THE EVALUATION OF THE UNIT. PER THE REQUEST ANALYSIS REPORT, THE RFC WAS SET-UP AND OPERATED WITH TWO DIFFERENT HL20 CONSOLE, FOR ONE WEEK 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 (EXCLUDING WEEKENDS) 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773924 ROTAFLOW CENTRIFUGAL PUMP SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS KFM MAQUET CARDIOPULMONARY AG 70105.1712

    Patients

    Seq Age Sex Outcome Treatment
    1