BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASAHI APS HEMODIALYZER

    MDR report key: 518770 · Received March 15, 2004

    Report

    Report Number
    518770
    Event Type
    Other
    Date Received
    March 15, 2004
    Date of Event
    November 4, 2003
    Report Date
    December 19, 2003
    Manufacturer
    NEXTRON MEDICAL
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED CHILLS FOLLOWING HEMODIALYSIS THERAPY. THERAPY WAS PROVIDED WITH A 3RD-USE HEMODIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI APS HEMODIALYZER HEMODIALYZER FKP NEXTRON MEDICAL APS1050S UNK
    2 RENATRON REPROCESSING DEVICE LIF MINNTECH CORP. RS8330 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other