BEUDAMED
    FDA Adverse Event Other Summary report: N

    PSN DIALYZER (PSN 170)

    MDR report key: 505919 · Received January 6, 2004

    Report

    Report Number
    1423500-2003-01341
    Event Type
    Other
    Date Received
    January 6, 2004
    Date of Event
    November 9, 2003
    Report Date
    December 10, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    NATIONAL COMPLAINT COORDINATOR (NCC) REPORTED ONE INCIDENT OF A PT REACTION WITH THE PSN 170 DIALYZER. IT WAS REPORTED THAT 48 MINUES INTO TREATMENT, THE PT EXPERIENCED ULTRAFILTRATION WAS CEASED AND OXYGEN ADMINISTERED (ROUTE AND DOSE UNKNOWN). NO CHANGE IN BP WAS REPORTED. THE BLOOD WAS RETURNED AND TREATMENT WAS RESUMED WITH A DICEA 90G DIALYZER. REPORTEDLY THE PT'S SYMPTOMS RESOLVED. THIS WAS THE THIRD OCCASION THAT THE PT HAD BEEN DIALYZED ON THE PSN DIALYZER AND REPORTEDLY, THE DIALYZER HAD BEEN PRIMED ACCORDING TO THE PRODUCT INFO SHEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSN DIALYZER (PSN 170) HOLLOW FIBER DIALYZER FJI BAXTER HEALTHCARE CORP. PSN 170 H03E12126

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R 205-S03M/IV), 2003,| BAXTER SALINE 0.9% (AHB1324), 2003,| TERUMO FISTULA NEEDLES (AV*E1525CL), 2003,| BAXTER PART A ACID (AHM7904), 2003.| BAXTER AURORA (S1000L3T/N101ARM), 2003,| BAXTER ALTRACART (500750A), 2003,| BAXTER BLOODLINES (MFR BY INFUS MED IN THAILAND