BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARDIOHELP SYSTEM

    MDR report key: 4580111 · Received March 4, 2015

    Report

    Report Number
    3008355164-2015-00020
    Event Type
    Death
    Date Received
    March 4, 2015
    Date of Event
    February 7, 2015
    Report Date
    February 7, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOHELP PUMP STOPPED FLOWING WHILE THE PT WAS BEING TURNED/MOVED. THE BLOOD FLOW COULD NOT BE RESTORED. THE PT EXPIRED. IT WAS REPORTED THAT THE UNIT WENT FROM 4 LITERS FLOW PER MINUTE TO ZERO LITERS FLOW PER MINUTE. ADD'L INFO: PT HAD AN OPEN CHEST. THIS EVENT IS RELATED TO MEDWATCH REPORT # 8010762-2015-00015 AND 3008355164-2015-0028 (HLS DISPOSABLE). (B)(4). MFR REF #: 8010762-2015-00068.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149466 ARDIOHELP SYSTEM CARDIOPULMONARY SUPPORT SYSTEM DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death