BEUDAMED
    FDA Adverse Event Other Summary report: N

    PSN DIALYZER (PSN 140)

    MDR report key: 517216 · Received January 28, 2004

    Report

    Report Number
    1423500-2004-00052
    Event Type
    Other
    Date Received
    January 28, 2004
    Date of Event
    November 1, 2003
    Report Date
    December 30, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PT EXPERIENCED ITCHING, HEAD SKIN RASH, AND FEELING OF EXTREME COLD WHILE BEING TREATED ON THE PSN 140 DIALYZER. PT WAS AFEBRILE AND CULTURES WERE NEGATIVE. IT WAS REPORTED THAT THE PT HAD PRESENTED WITH THESE SYMPTOMS DURING TREATMENT ON THE PSN 140 SINCE THE END OF NOVEMBER. THE PT WAS SUBSEQUENTLY SWITCHED TO AN ASAHI AMBIO 65 MEMBRANE. THE PT STILL REPORTED FEELING COLD, BUT TO A LESSER DEGREE AND DID NOT EXPERIENCE THE OTHER SYMPTOMS. THE PT HAS SINCE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSN DIALYZER (PSN 140) HOLLOW FIBER DIALYZER FJI BAXTER HEALTHCARE CORP. PSN 140 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other MEDISYSTEMS BLOODLINES, 2003.