BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET CARDIOHELP-I SYSTEM

    MDR report key: 3720407 · Received March 2, 2014

    Report

    Report Number
    3008355164-2014-00061
    Event Type
    Death
    Date Received
    March 2, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS PLACED ON THE CARDIOHELP WITH MENINGITIS WHICH CREATED CARDIAC FAILURE. THE INITIATION OF ECLS (EXTRACORPOREAL LIFE SUPPORT) WAS SUCCESSFUL BUT THERE WAS DIFFICULTY MAINTAINING SUFFICIENT FLOW. THE INITIAL FLOWS WERE 1.5 LITERS/MIN BUT SOON DROPPED TO 200-400 MLS/MIN AT 3000 RPM'S. THE CANNULAS APPEARED TO BE VERY SMALL AND THE PATIENT'S VOLUME WAS DEFICIENT. THE VENOUS PRESSURES HAD A VERY HIGH NEGATIVE READING WHILE THE ARTERIAL PRESSURE WAS NORMAL. THE DEATH IS ATTRIBUTED TO THE PATIENT'S POOR CONDITION AND NOT THE DEVICE. NO DEVICE MALFUNCTION WAS REPORTED. (B)(4). REF MFR REPORT 8010762-2014-00146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125682 MAQUET CARDIOHELP-I SYSTEM CARDIOHELP-I SYSTEM DTQ MAQUET CARDIOPULMONARY AG 70104.8012 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death