BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPULMONARY DEVICE

    MDR report key: 2112936 · Received May 25, 2011

    Report

    Report Number
    2248146-2011-00255
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THERE WAS A LINE SEPARATION OF A LINE WITHIN A CUSTOMER PACK CONTAINING THE PLAGIOX CARDIOPLEGIA HEAT EXCHANGER. IT APPEARS THIS OCCURRED WHILE BEING USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPULMONARY DEVICE DSP DATASCOPE CORP. 12964

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK