BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    01950110#QUADROX-I SMALL

    MDR report key: 3831980 · Received March 7, 2014

    Report

    Report Number
    8010762-2014-00125
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY
    Product Code
    DTZ
    PMA / PMN Number
    K090689
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED AT OUR FACILITY FOR INVESTIGATION. THE SAMPLE HAS BEEN REQUESTED FROM THE CUSTOMER AND A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ONCE THE SAMPLE IS RETURNED AND FURTHER INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE QUADROX-I LEAKED UPON PRIMING AT 3/8 OUTLET. REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139049 01950110#QUADROX-I SMALL MICROPOROUS MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY 70103.6073 70093582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA