BEUDAMED
    FDA Adverse Event Other Summary report: N

    PSN DIALYZER (PSN 210)

    MDR report key: 236574 · Received August 17, 1999

    Report

    Report Number
    1423500-1999-00957
    Event Type
    Other
    Date Received
    August 17, 1999
    Date of Event
    July 8, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    KDI
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A PT COMPLAINED OF A WARM SENSATION, ITCHING AND SHORTNESS OF BREATH 30 MINUTES INTO THE PT TREATMENT. THE PT WAS ALSO NOTED TO HAVE PULMONARY EDEMA WITH DYSPNEA AND WHEEZING. BP AT TIME OF EVENT= 142/73, PULSE= 83. THE PT WAS REMOVED FROM THE TREATMENT ND TREATED WITH 5L OXYGEN PER NASAL CANNULA, 25MG BENADRYL AND A NEBULIZER TREATMENT. THE PT WAS THEN TRANSPORTED TO THE HOSPITAL FOR OBSERVATION. A HEMODIALYSIS TREATMENT WAS PERFORMED IN THE HOSPITAL USING A CELLULOSE ACETATE MEMBRANE. THE PT WAS THEN RELEASED TO HOME FULLY RECOVERED, THIS EVENT OCCURRED AFTER THE PT'S FIRST EXPOSURE TO THE PSN MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSN DIALYZER (PSN 210) HOLLOW FIBER DIALYZER KDI BAXTER HEALTHCARE CORP PSN 210 H99D28161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other