BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4888501 · Received July 1, 2015

    Report

    Report Number
    3008355164-2015-00136
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 16, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE UNIT DISPLAYED ERROR AND STOPPED PUMPING. THE UNIT WAS POWERED OFF AND ON BUT THE ALARM WOULD NOT RESET. CYCLED POWER 3 TIMES, UNABLE TO RESET ALARM. PATIENT WAS MOVED TO BACK UP CONSOLE. NO REPORTED PATIENT EFFECT. (B)(4). REFERENCE MFR # 8010762-2015-00764.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428496 ROTAFLOW CENTRIFUGAL PUMP SYSTEM KFM MAQUET CARDIOPULMONARY AG US US-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention