BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIACIDE DIALYZER

    MDR report key: 333849 · Received May 17, 2001

    Report

    Report Number
    1221361-2001-00003
    Event Type
    Injury
    Date Received
    May 17, 2001
    Date of Event
    April 18, 2001
    Report Date
    April 18, 2001
    Manufacturer
    ALDEN, A DIV OF METREX RESEARCH CORP
    Product Code
    FKQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NURSE MANAGER REPORTED THAT WHILE 6 PTS WERE HOOKED UP TO KIDNEY DIALYSIS TREATMENT, THEY SIMULTANEOUSLY EXPERIENCED CLASSIC GLUTARALDEHYDE EXPOSURE SYMPTOMS (BAD TASTE IN MOUTH, DROP IN BLOOD PRESSURE, SHORTNESS OF BREATH). THE DIALYSIS TREATMENT WAS IMMEDIATELY DISCONTINUED AND ALL 6 PTS RECEIVED PROMPT MEDICAL TREATMENT FROM THE NURSES ON-SITE. ONE PT WAS HOSPITALIZED OVERNIGHT. ALL SYMPTOMS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23214 DIACIDE DIALYZER DISINFECTANT FOR DIALYZERS FKQ ALDEN, A DIV OF METREX RESEARCH CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening