BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-ID ADULT

    MDR report key: 2852963 · Received November 21, 2012

    Report

    Report Number
    8010762-2012-00048
    Event Type
    Death
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. ITEMS MARKED NI ARE UNK TO US AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD MYOCARDIAL INFARCTION AND HAD BEEN PLACED ON VV SUPPORT ON (B)(6) 2012. ON (B)(6) 2012, A PERFUSIONIST WAS CALLED TO THE HOSPITAL WHEN THE FLOW WENT FROM 6 TO 2 LITERS. THE PERFUSIONIST FOUND A CLOT ON THE PROXIMAL SIDE OF THE OXYGENATOR WHICH HAD BEEN UNNOTICED. IT WAS FELT THAT THE PT'S VITALS HAD NOT CHANGED SINCE THERAPY HAD STARTED AND THE DECREASED FLOW HAD NOT AFFECTED THE PATIENT'S CONDITION. THE PUMP WAS SHUT OFF. THE PT EXPIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-ID ADULT OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG NA 70075647

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death