BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F70 HEMOFLOW DIALYZER12/CS

    MDR report key: 191818 · Received October 14, 1998

    Report

    Report Number
    1713747-1998-00888
    Event Type
    Injury
    Date Received
    October 14, 1998
    Report Date
    September 15, 1998
    Manufacturer
    FRESENIUS
    Product Code
    FJI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY NOTIFIED QUALITY SYSTEMS DIRECTLY CONCERNING FOUR REPORTED "BLOOD LEAKS". ALL WERE SAME LOT NUMBERS. HAVE REQUESTED FURTHER CLINICAL INFO TO DETERMINE NUMBER OF COMPLAINTS TO BE FILED ON 09/16/1998 (TWO MESSAGES LEFT FOR HEALTH CARE PROFESSIONAL). ON 09/18/1998 AND 09/21/1998 FURTHER TELEPHONE CALLS WERE MADE TO GATHER INFO FOR EVALUATION OF THIS COMPLAINT AND THE CONDITION OF THE INVOLVED PTS. 09/21/1998 INFO GIVEN BY HEALTH CARE PROFESSIONAL REPORTING 240 ML BLOOD LOSS TO EACH OF THE FOUR AFFECTED PTS WITH NO ADVERSE EFFECTS, DUE TO DISCARD OF THE EXTRACORPOREAL CIRCUIT. BLOOD WAS VISIBLE IN THE DIALYSATE AT TREATMENT START. THE LEAKS REPORTEDLY OCCURRED WITHIN A TWO WEEK PERIOD. NONE OF THE ACTUAL SAMPLES WERE SAVED. INDIVIDUAL MDRS FILED DUE TO REPORTED BLOOD LOSSES. NO FURTHER INFO IS AVAILABLE. THIS IS FIRST LEAK COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F70 HEMOFLOW DIALYZER12/CS HIGH FLUX DIALYZER FJI FRESENIUS F70NR 7N01708

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HEMODIALYSIS 3XWEEK.