BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROXI D PEDIATRIC OXYGENATOR

    MDR report key: 4210854 · Received August 1, 2014

    Report

    Report Number
    2248146-2014-00322
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 17, 2011
    Report Date
    June 24, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NON-CONFORMITY REPORTED STATED: OXYGENATOR HAD TO BE CHANGED FOR ANOTHER AFTER TWO DAYS OF USE DUE TO CLOTTING INT HE UNIT. ON (B)(4) 2011 EMAIL FROM TERRITORY MANAGER STATED: CUSTOMER IS NOT NECESSARILY SUGGESTING OXYGENATORS WERE DEFECTIVE IN SOME WAY. IN THE FIELD WE HAVE BEEN DIRECTED TO REPORT ANY HICCUP WITH A PRODUCT. ANTI-COAGULATION MANAGEMENT OF THESE DEVICES IS COMPLEX. NO NEGATIVE PATIENT CONSEQUENCES RESULTED. OXYGENATORS ARE TO BE USED FOR A MAXIMUM OF 6 HOURS AS STATED IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452144 QUADROXI D PEDIATRIC OXYGENATOR CARDIOPULMONARY DEVICE DTZ DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1