BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOGIC DT TREATMENT KIT

    MDR report key: 66042 · Received January 2, 1997

    Report

    Report Number
    66042
    Event Type
    Malfunction
    Date Received
    January 2, 1997
    Date of Event
    September 13, 1996
    Report Date
    September 20, 1996
    Manufacturer
    HEMACLEANSE, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING LIVER DIALYSIS FOR ACUTE HEPATIC FAILURE, ALARM SOUNDED INDICATING SORBENT TEMP ELEVATION GREATER THAN 40.5 DEGREES C. SYSTEM AUTOMATICALLY SHUT DOWN. ESTIMATED BLOOD LOSS BECAUSE BLOOD COULD NOT BE RETURNED TO PT WAS 200CC. SHUT DOWN OCCURRED AT ONSET OF THERAPY. DIALYSIS ABORTED; REDIALYSIS COMPLICATED WITH BLEEDING FROM ACCESS SITE AND THERAPY COULD NOT BE COMPLETED. PT EVENTUALLY EXPIRED WITHIN 24 HRS. LIVER DIALYSIS WAS INITIATED AS ONLY REMAINING TREATMENT CHOICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOGIC DT TREATMENT KIT LIVER DIALYSIS TREATMENT KIT LKN HEMACLEANSE, INC. NI 1302

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other MODEL # DT1006, SERIAL # DT 009557| BIOLOGIC DT EXTRACORPOREAL SYSTEM BLOOD DETOXIFIER