BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SE4T W/BIOLINE COATING

    MDR report key: 4470316 · Received January 29, 2015

    Report

    Report Number
    8010762-2015-00041
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    December 29, 2014
    Report Date
    December 31, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL PENDING. ADDITIONAL INFO: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510(K): K101153. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CONNECTED TO A PT, BLOOD LEAKAGE WAS DETECTED UNDER THE OXYGENATOR OF THE ECMO CIRCUIT AFTER STARTING THE ASSISTANCE PUMP. THE DECISION WAS MADE TO CHANGE THE CIRCUIT IMMEDIATELY, DESPITE THE SEPTIC AND HEMORRHAGIC RISKS. ECMO - EXTRA CORPOREAL MEMBRANE OXYGENATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68236 HLM TUBING SE4T W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BE-PLS 2051 70099760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention