BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA APHERESIS TUBING SET

    MDR report key: 707800 · Received December 9, 2005

    Report

    Report Number
    1722028-2005-00001
    Event Type
    Other
    Date Received
    December 9, 2005
    Date of Event
    October 8, 2005
    Report Date
    December 8, 2005
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE COMPLETION OF AN 8 UNIT RED BLOOD CELL EXCHANGE PROCEDURE, THE FACILITY STAFF NOTICED THAT NO RED BLOOD CELLS HAD BEEN REMOVED, HOWEVER RED BLOOD CELLS WERE GIVEN TO THE PT. THE PT'S BLOOD PRESSURE ELEVATED. THE FACILITY STAFF PERFORMED A THERAPUETIC PHLEBOTOMY AS A PRECAUTION. FOLLOWING, THE FACILITY STAFF PERFORMED ANOTHER RED BLOOD CELL EXCHANGE PROCEDURE TO BRING THE HEMATOCRIT FROM 47% TO 30%. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA APHERESIS TUBING SET RED BLOOD CELL EXCHANGE SET LKN GAMBRO BCT, INC. * 06L15265

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other