BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOHELP

    MDR report key: 3882981 · Received May 29, 2014

    Report

    Report Number
    3008355164-2014-00108
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS ON VENO-VENO EXTRACORPOREAL LIFE SUPPORT, WHEN THEY NOTICED AIR INFILTRATING ON THE ARTERIAL SIDE OF THE CIRCUIT. IT WAS NOTED THAT THE BUBBLE DETECTOR WAS NOT DETECTING THE INFILTRATING AIR. PRIOR TO USING THE CARDIOHELP IT WAS MENTIONED THAT THE PT'S VENOUS PRESSURES WHERE IN-APPROPRIATE AFTER THE CALIBRATION, SO A SEPARATE VENOUS PRESSURE TRANSDUCER WAS TETHERED TO THE CARDIOHELP DISPOSABLE CIRCUIT TO MONITOR PRESSURES. SINCE THE BUBBLE DETECTOR WAS NOT DETECTING WHAT APPEARED TO BE AIR ENTERING THE SYSTEM, THE DECISION WAS MADE TO SWAP THE UNIT AND THE DISPOSABLE. NO PT EFFECT WAS REPORTED. (B)(4). REF. MFR # 8010762-2014-00220.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316260 MAQUET CARDIOHELP CARDIOHELP DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention