BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 1152004 · Received August 20, 2008

    Report

    Report Number
    MW5008228
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BAXTER CORPORATION
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PATIENT'S RED CELL EXCHANGE, PHERESIS, THE MACHINE'S CENTRIFUGE CLOTTED. WE BEGAN THE PROCEDURE USING OUR FIRST MACHINE, BUT WHEN THE CENTRIFUGE CLOTTED, WE ABORTED THAT PROCEDURE AND RE-STARTED THE PROCEDURE ON OUR SECOND MACHINE. AFTER 1 UNIT OF PRBCS INFUSED ON THE SECOND MACHINE, THE CENTRIFUGE AGAIN CLOTTED OFF. PATIENT'S PHYSICIAN, DR. TOM HOWARD, FEELS THAT THE CENTRIFUGE CONTINUED TO CLOT OFF DUE TO THE ANTI-COAGULANT, CITRATE, WE USE NOT BEING EFFECTIVE. THE CITRATE LOT NUMBER FOR BOTH PROCEDURES IS C746354, EXP JAN 2010, AND IT IS MADE BY BAXTER. DOSE OR AMOUNT: 500ML BAG; FREQUENCY: DURING PHERESIS; ROUTE: IV. DATES OF USE: 2008, THREE HOURS. DIAGNOSIS OR REASON FOR USE: USED AS ANTI-COAGULANT DURING RED CELL EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER CITRATE LKN BAXTER CORPORATION C746354

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other BAXTER| CITRATE| 730 MG CITRIC ACID