BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CONSOLE

    MDR report key: 4142534 · Received October 1, 2014

    Report

    Report Number
    8010762-2014-00735
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INVESTIGATED BY A MAQUET FIELD SERVICE TECHNICIAN. THE SYSTEM WAS CHECKED USING A TERMINAL EMULATOR. THE RESULTS WERE NORMAL. THE RF-DRIVE WAS CLEANED OF DUST, PARTICULAR ATTENTION WAS PAID TO TACHO. RE-SEATED ALL PCB CONNECTIONS WITHIN THE ROTAFLOW CONSOLE. SUCCESSFUL RUN ON EXTENDED TEST. TOPPED OFF THE HYDRAULIC OIL. A SUPPLEMENTAL MEDWATCH WILL BE ISSUED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING SUPPORTED WITH VA ECMO (VENOUS ACCESS EXTRA CORPOREAL MEMBRANE OXYGENATION)VIA A ROTAFLOW DEVICE, WHEN AN ERROR AND ALARM OCCURRED AND FLOW WITHIN THE CIRCUIT CEASED. ROTAFLOW 32 PUMP TRANSFERRED TO EMERGENCY PUMP DRIVE AND PATIENT SUPPORT WAS RESUMED. ROTAFLOW CONSOLE TURNED OFF AND RESTARTED WITHOUT INCIDENT AND PATIENT ROTAFLOW32 WAS PLACED BACK IN THE PUMP DRIVE. THE ROTAFLOW SYSTEM WAS SWAPPED OUT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611560 ROTAFLOW CONSOLE ROTAFLOW CONSOLE KFM MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention