BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 4869438 · Received June 24, 2015

    Report

    Report Number
    3008355164-2015-00134
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR OCCURS WHEN OVER 1.000RPM DURING SURGERY. THE UNIT WAS EXCHANGED. (B)(4). MFR REF# 8010762-2015-00755.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408963 ROTAFLOW CENTRIFUGAL PUMP SYSTEM KFM MAQUET CARDIOPULMONARY AG MCP00706035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention