BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN DIALYZER (PSN 210)

    MDR report key: 515892 · Received March 12, 2004

    Report

    Report Number
    1423500-2004-00229
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    February 16, 2004
    Report Date
    February 17, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT TWO MINUTES INTO THE PT'S FIRST TREATMENT USING A PSN 210 DIALYZER, PT EXPERIENCED RESPIRATORY DISTRESS, RESTLESSNESS AND PROFUSE PERSPIRATION. AT THIS TIME THE PT'S BLOOD PRESSURE WAS 250/150, HEART RATE WAS 133, O2 SATURATION WAS 89% ON ROOM AIR. THE TREATMENT WAS IMMEDIATELY STOPPED AND BLOOD WAS NOT RETURNED TO THE PT. THE PT WAS ADMINISTERED; 50 MG IV BENADRYL, 4 L/MIN O2 PER VENTIMASK AND 125 MG IV SOLUMEDROL WITH LITTLE RELIEF OF SYMPTOMS. THE PT'S O2 DID INCREASE TO 95% WITH 4L/MIN O2, PT REMAINED IN DIALYSIS UNIT FOR OBSERVATION, HOWEVER THEIR SYMPTOMS DID NOT FULLY RESOLVE. ANOTHER 50MG IV BENADRYL ADMINISTERED. THE PT WAS THEN ADMITTED TO THE HOSP WHERE PT WAS DIALYZED WITH A POLYFLUX DIALYZER AND OBSERVED OVERNIGHT. THE PT WAS DISCHARGED 2 DAYS LATER. PT RECEIVED NEBULIZER TREATMENTS AND A CHEST X-RAY AND WAS ON CARDIAC MONITORING DURING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSN DIALYZER (PSN 210) HOLLOW FIBER DIALYZER FJI BAXTER HEALTHCARE CORP. PSN 210 H04A08023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R PHOENIX HEMODIALYSIS MACHINE 2004,| PHOENIX BLOODLINES, 2004.