BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER

    MDR report key: 364210 · Received November 19, 2001

    Report

    Report Number
    MW4003143
    Event Type
    Injury
    Date Received
    November 19, 2001
    Date of Event
    October 1, 2001
    Report Date
    November 19, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP GLP
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAS BEEN ON DIALYSIS WITH BAXTER MACHINES, 3 TIMES PER WEEK. IN OCTOBER PT HAD 3 REACTIONS IN ONE WEEK, AND THE THIRD REACTION WAS MOST SEVERE. PT LOST CONTROL OF ALL BODILY FUNCTIONS. DR GAVE SHOTS OF BENADRYL TO ALLEVIATE SYMPTOMS. THE DRS SAID PT HAD AN ALLERGIC REACTION TO THE CHEMICALS USED TO CLEAN THE DIALYSIS MACHINES. PT HAS TO USE A NEW MACHINE EVERY TIME, AND HAS SINCE NOT HAD ANY MORE ADVERSE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52324 BAXTER DIALYSIS MACHINE FII BAXTER HEALTHCARE CORP GLP NI NA
    52325 BAXTER DIALYZER FJI BAXTER HEALTHCARE CORP GLP F8 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO