BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BO-HLS 7050 ADVANCED 7.0

    MDR report key: 3896917 · Received May 31, 2014

    Report

    Report Number
    3008355164-2014-00107
    Event Type
    Injury
    Date Received
    May 31, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 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 AN OPERATOR NOTICED VISIBLE AIR IN THE APEX OF THE HLS-MODULE, WITH NO KNOWN EXPLANTATION AS TO HOW THE AIR INFILTRATED THE UNIT, RESULTING IN THE PATIENT'S PAO2 DROPPING. THE OPERATOR SUSPECTED A MEMBRANE FAILURE. THE DEVICE WAS SWAPPED OUT. NO REPORTED PATIENT EFFECT. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320610 BO-HLS 7050 ADVANCED 7.0 HLS SET ADVANCED 7.0 DTQ MAQUET CARDIOPULMONARY AG BO-HLS 7050 USA 7092306

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention