BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING - SET INC. OXYGENATOR

    MDR report key: 4733236 · Received April 24, 2015

    Report

    Report Number
    8010762-2015-00401
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 27, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY HAS RECEIVED THE PRODUCT IN QUESTION FOR EVALUATION ON (B)(4) 2014. THE EVALUATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN NEW INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-I) IS REGISTERED UNDER 510 (K): K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS PER START OF THE PRIMING PROCEDURE WITH PLASMALYTE, AT LOW FLOW 1LPM (LITER PER MINUTE) AND LOW PRESSURE, PRIMING FLUID LEAKS THROUGH THE GAS OUTLET OF THE OXYGENATOR. ADDITIONALLY IT WAS REPORTED THAT NO WATER LEAK INSIDE THE BLOOD COMPARTMENT WAS FOUND. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273453 CUSTOM TUBING - SET INC. OXYGENATOR DWE MAQUET CARDIOPULMONARY AG 70104.5308 92121819

    Patients

    Seq Age Sex Outcome Treatment
    1