BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENAFLO II

    MDR report key: 542551 · Received September 2, 2004

    Report

    Report Number
    542551
    Event Type
    Other
    Date Received
    September 2, 2004
    Date of Event
    August 20, 2004
    Report Date
    August 31, 2004
    Manufacturer
    MINNTECH CORP.
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INVESTIGATION ONGOING - RESULTS PENDING. ADVERSE EVENT DUE TO POSSIBLE FILTER SEAL FAULT. REPORT WILL BE AMENDED AS INDICATED UPON COMPLETION OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAFLO II HEMOFILTER FKJ MINNTECH CORP. HF 400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other # 453302-2004-19.| BAXTER BM25 CVVH UNIT SEE UF REPORT