BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN DIALYZER (PSN 210)

    MDR report key: 515884 · Received March 12, 2004

    Report

    Report Number
    1423500-2004-00230
    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. AT THE TIME PT'S BP WAS 250/150, AND PT WAS TACHYCARDIC, O2 SATURATION WAS 80% ON ROOM AIR. THE TREATMENT WAS IMMEDIATELY STOPPED; BLOOD WAS NOT RETURNED TO PT. 50 MG IV BENADRYL AND 2 L/MIN O2 VIA VENTIMASK WERE ADMINISTERED WITH RELIEF OF SYMPTOMS. THE PT'S O2 DID INCREASE TO 98% WITHIN FIVE MINUTES OF ADMINISTRATION OF 2L/MIN O2. THE PT'S BP DECREASED TO 160/70 ALSO WITHIN 5 MINUTES OF REMOVAL FROM TREATMENT. THIRTY MINUTES FOLLOWING REMOVAL OF DIALYSIS, THE PT CONTINUED TO WHEEZE. 125 MG IV SOLUMEDROL WAS ADMINISTERED WITH RELIEF. WITHIN ONE HOUR AFTER REMOVAL FROM DIALYSIS, THE PT RESTARTED THEIR TREATMENT USING AN F8 DIALYZER. THE TREATMENT WAS UNEVENTFUL AND THE PT IS FULLY RECOVERED PER HCP.

    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 H04A0823

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention PHOENIX BLOODLINES, 2004.| PHOENIX HEMODIALYSIS MACHINE 2004,