BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-I WITH FILTER

    MDR report key: 3915692 · Received June 12, 2014

    Report

    Report Number
    8010762-2014-00232
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K090511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE SAMPLE HAS BEEN REQUESTED FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, A PT'S OXYGEN LEVEL WAS AT 100%, THE GAS SWEEP FLOW WAS HIGH AT EIGHT LITERS/MIN, 50MM/HG OF O2 AND THE CO2 WAS 70. THERE WAS NO GAS EXCHANGE AND NO GRADIENT ACROSS THE OXYGENATOR. NO REPORTED CLOTTING. REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346795 QUADROX-I WITH FILTER QUADROX-I OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 01971110 70095988

    Patients

    Seq Age Sex Outcome Treatment
    1 Other