BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPE PLASMA EXCHANGE SET 5/CASE

    MDR report key: 366210 · Received December 14, 2001

    Report

    Report Number
    3033270-2001-00002
    Event Type
    Injury
    Date Received
    December 14, 2001
    Date of Event
    December 9, 2001
    Report Date
    December 14, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LKN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH THROMBOTIC THROMBOCYTOPENIC PURPURA BECAME UNRESPONSIVE DUE TO HYPOVOLEMIA DURING A PLASMA EXCHANGE PROCEDURE. PATIENT WAS RESUSCITATED WITH 1 LITER IV FLUIDS. THE PATIENT STABILIZED WITH NO SEQUELAE. EVALUATION OF MACHINE AND DISPOSABLE REVEALED THAT REPLACEMENT PUMP SEGMENT ON DISPOSABLE HAD A SMALLER LUMEN SIZE THAN NORMAL CAUSING THE PATIENT TO RECEIVE INADEQUATE REPLACEMENT VOLUME WHICH WAS NOT REFLECTED IN TOTAL VOLUME DISPLAYED FOR THAT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57123 TPE PLASMA EXCHANGE SET 5/CASE DISPOSABLE FOR CELL SEPARATOR MACHINE LKN FRESENIUS HEMOCARE, INC. 9008201 LMT 193

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization