BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET

    MDR report key: 4997088 · Received August 11, 2015

    Report

    Report Number
    3008355164-2015-00156
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 12, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4). REFERENCE MFR # 8010762-2015-00875.

    Description of Event or Problem · 1

    (B)(4). MFR REF# 8010762-2015-00875.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A CLOTTING PROBLEM AND PRESSURE ISSUES WITH THE DEVICE. THE DEVICE FAILED AND WAS REPLACED. THE PATIENT WAS EVENTUALLY STABILIZED AND REMOVED FROM ECLS MACHINE, BUT DID PASS AWAY. ECLS - EXTRACORPEAL LUNG SUPPORT. (B)(4). MFR REF#8010762-2015-00875.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523414 HLM TUBING SET DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death