BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKE

    MDR report key: 959850 · Received May 3, 2007

    Report

    Report Number
    2647898-2007-00008
    Event Type
    Malfunction
    Date Received
    May 3, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 4, 2007
    Manufacturer
    PALL BIOMEDICAL, INC.
    Product Code
    JOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BEGUN, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INSPECTION OF THE DEVICES, PRIOR TO SHIPMENT TO ANOTHER MANUFACTURER, FREE PARTICULATE MATTER WAS DISCOVERED IN THE DOWNSTREAM SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKE JOD: CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FI JOD PALL BIOMEDICAL, INC. CPS02NS 632002

    Patients

    Seq Age Sex Outcome Treatment
    1