BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRON MEDICAL TECHNOLOGIES, INC

    MDR report key: 246776 · Received October 25, 1999

    Report

    Report Number
    2244060-1999-00018
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    July 22, 1999
    Report Date
    October 22, 1999
    Manufacturer
    NEXTRON MEDICAL TECHNOLOGIES
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTED THAT THE BLOOD TUBING/PUMP SEGMENT FAILED AFTER RUNNING FOR OVER 48 HOURS. THE CLINIC'S COMPLAINT CONSISTED OF 6 INCIDENTS INVOLVING 5 PTS. ADDITIONALLY, 3 OF THE INCIDENTS WHICH OCCURRED WERE ASSOCIATED WITH AN UNKNOWN LOT NUMBER. IT IS UNCLEAR WHICH PTS EXPERIENCED PROBLEMS WITH MORE THAN ONE BLOOD TUBING SET, WHICH DATES THE INCIDENTS OCCURRED, THE AMOUNT OF BLOOD LOSS (CLINIC ADVISED THAT IT WAS LESS THAN 150CCS, HOWEVER, CLINIC COULD NOT CONFIRM ACTUAL AMOUNT OF BLOOD LOSS PER PT), AND, TO WHAT EXTENT PT INTERVENTION WAS REQUIRED. THESE SAME FACTS APPLY TO MDR NOS. 2244060-1999-00014 THROUGH 00017 AND 2244060-1999-00019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXTRON MEDICAL TECHNOLOGIES, INC BLOOD TUBING SET FJK NEXTRON MEDICAL TECHNOLOGIES 505/PAN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other