BEUDAMED
    FDA Adverse Event Death Summary report: N

    BEQ-HMOD70000-USA

    MDR report key: 2996777 · Received March 6, 2013

    Report

    Report Number
    8010762-2013-00012
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A REVIEW OF THE MFG RECORDS SHOWED NO NON-CONFORMANCES. ACCORDING TO CUSTOMER, A HYPER-COAGULATION DISORDER IN THE PT MAY HAVE CAUSED THE CLOTTING ISSUES AND THEY DO NOT ATTRIBUTE THE PT'S DEATH TO THE OXYGENATOR. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS THE DEVICE IS RETURNED TO THE MFR AND ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 15 MINUTES OF EMERGENCY CIRCULATORY SUPPORT USING A QUADROX-ID OXYGENATOR THE FLOW WAS OBSTRUCTED AND DECREASED TO UNDER 0.5 LPM. A SECOND QUADROX-ID OXYGENATOR WAS ADDED TO THE CIRCUIT TO REPLACED THE FIRST OXYGENATOR. FULL FLOW WAS REGAINED FOR LESS THAN 5 MINUTES AND THEN DECREASED TO NEAR ZERO LPM. THE CUSTOMERS INITIAL IMPRESSION WAS THE PROBLEM WAS CAUSED BY A HYPERCOAGULATION ISSUE WITH THE PT. THE PT WAS REPORTED TO HAVE EXPIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95194 BEQ-HMOD70000-USA OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA 70083399

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death