BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BE-HLS 7050#HLS SET ADVANCED 7.0

    MDR report key: 4338243 · Received December 9, 2014

    Report

    Report Number
    8010762-2014-01346
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 14, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    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

    MAQUET CARDIOPULMONARY HAS REQUESTED THE TUBING SET BACK FOR EVALUATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 15 MINUTES AFTER INITIATING VENO-VENOUS ECMO, A SMALL BLOOD LEAK WAS NOTED AT THE GAS OUTLET OF THE DEVICE. A FEW MINUTES LATER, WHEN MOVING THE PATIENT, AIR INTAKE WAS OBSERVED AT THE ARTERIAL SIDE OF THE DEVICE. THE BUBBLE SENSOR DETECTED THE AIR AND THE DEVICE STOPPED. NO CLINICAL CONSEQUENCES WERE REPORTED FOR THE PATIENT. ECMO-EXTRA CORPOREAL MEMBRANE OXYGENATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792810 BE-HLS 7050#HLS SET ADVANCED 7.0 TUBING SET DTQ MAQUET CARDIOPULMONARY AG 70096451

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention