BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX ID PEDIATRIC

    MDR report key: 4210833 · Received August 1, 2014

    Report

    Report Number
    2248146-2014-00318
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    August 31, 2011
    Report Date
    October 5, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE PEDIATRIC QUADROX ID WAS OBSERVED TO HAVE A LARGE CLOT ON THE ARTERIAL SIDE AFTER 3 DAYS OF BYPASS. THE PERFUSIONIST DECIDED TO ELECTIVELY CHANGE OUT THE OXYGENATOR. THE UNIT WAS PART OF A PACK AND LOT NUMBERS WERE NOT PROVIDED AS OF 9PM (B)(6) 2011. THE QUADROX WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451939 QUADROX ID PEDIATRIC CARDIOPULMONARY DEVICE DTZ DATASCOPE CORP. BEQ TOP-3706

    Patients

    Seq Age Sex Outcome Treatment
    1