BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4731211 · Received April 24, 2015

    Report

    Report Number
    3008355164-2015-00076
    Event Type
    Injury
    Date Received
    April 24, 2015
    Date of Event
    March 24, 2015
    Report Date
    March 26, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ECLS CASE BLOOD LEAKAGE FROM THE GAS OUTLET WAS OBSERVED. THE LEAKAGE WAS SEVERE ENOUGH TO REPLACE THE CIRCUIT IMMEDIATELY. NO REPORTED PT EFFECT. ECLS- EXTRA-CORPOREAL LUNG SUPPORT. (B)(4). MFR REF #: 8010762-2015-00376.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274086 HLM TUBING SET W/BIOLINE COATING DTZM (OR DWE) DTZ MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention