BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX OXYGENATOR

    MDR report key: 4212664 · Received October 24, 2014

    Report

    Report Number
    2248146-2014-00450
    Event Type
    Death
    Date Received
    October 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL, THEREFORE, WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. BECAUSE OF THE PASSING OF THE PT, THE DEVICE WAS GIVEN TO THE HOSPITAL'S RISK MGMT DEPT TO CONDUCT AN INVESTIGATION. THE HOSP REPORTED BACK THAT NO MANUFACTURING ISSUES WITH THE DEVICE WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS OPENED FOR THE SECOND DEVICE USED BY THE FACILITY BECAUSE A DEATH WAS REPORTED. THE FACILITY REPORTED THAT ANOTHER CIRCUIT WAS OPENED WHEN FIRST WAS IN QUESTION. NO REPORTED MALFUNCTION OF THIS SECOND DEVICE. FOR THE FIRST DEVICE, AIR WAS SEEN IN THE VENOUS LINE. REFERENCE COMPLAINT FOR THE FIRST DEVICE IS MFR REPORT #: 2248146-2014-00145.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680080 QUADROX OXYGENATOR CARDIOPULMONARY DEVICE DWE DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death