BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP

    MDR report key: 3787533 · Received April 11, 2014

    Report

    Report Number
    3008355164-2014-00080
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTAFLOW DEVICE SHUT OFF WHILE ON A PATIENT. NO FURTHER INFORMATION WAS PROVIDED. (B)(4). REFERENCE MFR REPORT 8010762-2014-00179.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222941 ROTAFLOW CENTRIFUGAL PUMP ROTAFLOW KFM MAQUET CARDIOPULMONARY AG 70105.1712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other