BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEQ-QUADROX-ID OXYGENATOR

    MDR report key: 4223676 · Received August 5, 2014

    Report

    Report Number
    8010762-2014-00278
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND CORRECTIVE ACTIONS FOR THE DEVICE DESCRIBED IN THIS REPORT. BASED ON THE REPORTED EVENT AND INVESTIGATION, THE REPORTED EVENT WAS CAUSED BY USE THAT IS BEYOND THE USAGE DESCRIBED IN OUR LABELING AND CLEARED INTENDED USE. A MAQUET TERRITORY MANAGER EXPLAINED TO THE CLINICIAN THAT METHYLENE BLUE IS CONTRAINDICATED IN THE DEVICE IFU. HE EXPLAINED THAT METHYLENE BLUE CAN CROSS THE POLYURETHANE HEAT EXCHANGER AND ENTER THE WATER BATH OF THE HEAT EXCHANGE DEVICE. ONCE IN THE WATER OF THE HEAT EXCHANGER, METHYLENE BLUE CHANGES MOLECULAR CONFIGURATION AND CANNOT GO BACK ACROSS THE POLYURETHANE HEAT EXCHANGER BACK INTO THE BLOODSTREAM. THIS OCCURS AT A MOLECULAR AND BACTERIOSTATIC LEVEL. THIS CAN ALTER THE BLOOD PLASMA LEVEL AND CONCENTRATION OF THE METHYLENE BLUE FOR THE PATIENT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METHYLENE BLUE WAS UTILIZED THE FIRST DAY OF ECLS (EXTRA-CORPOREAL LIFE SUPPORT) FOR "VASOPLEGIA SYNDROME" IN AN ATTEMPT TO IMPROVE BLOOD PRESSURE AND CENTRAL HEMODYNAMICS. FORTY EIGHT HOURS AFTER USE, THE WATER BATH WAS TINGED BLUE. THE VENOUS BLOOD COLOR WAS ALSO NOTED TO BE MUCH DARKER, WITH SOME BLUE DISCOLORATION NOTED ON THE VENOUS TUBING. THE PATIENT WAS WITHOUT FEVER AND RESPONDING FAVORABLY TO ECLS THERAPY. THE PATIENT WAS SUCCESSFULLY REMOVED FROM SUPPORT ON DAY FIVE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456061 BEQ-QUADROX-ID OXYGENATOR DIFFUSION MEMBRANE OXYGENATOR DTM MAQUET CARDIOPULMONARY AG 70105.3325 70091548

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR