BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER REPROCESSING SYSTEM

    MDR report key: 32199 · Received March 18, 1996

    Report

    Report Number
    32199
    Event Type
    Malfunction
    Date Received
    March 18, 1996
    Date of Event
    February 28, 1996
    Report Date
    March 15, 1996
    Manufacturer
    SERATRONICS/FRESENIUS USA, INC.
    Product Code
    LIF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DID NOT INSTILL PROPER FORMALDEHYDE CONCENTRATION TO DISINFECT THE ARTIFICIAL KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER REPROCESSING SYSTEM DIALYZER REPROCESSING SYSTEM LIF SERATRONICS/FRESENIUS USA, INC. DRS4

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other