BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRON MEDICAL TECHNOLOGIES, INC

    MDR report key: 239532 · Received September 8, 1999

    Report

    Report Number
    2244060-1999-00004
    Event Type
    Malfunction
    Date Received
    September 8, 1999
    Date of Event
    January 22, 1999
    Report Date
    September 8, 1999
    Manufacturer
    NEXTRON MEDICAL TECHNOLOGIES
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CLINIC ADVISED THAT BLOOD TUBING/PUMP SEGMENT FAILED AFTER APPROXIMATELY 8 HRS OF USE. BLOOD AND DEVICE WERE DISCARDED AFTER INCIDENT. THE CLINIC DID NOT PROVIDE INFO TO DETERMINE THE EXTENT, IF ANY, OF PT INTERVENTION REQUIRED. THE CLINIC HAS FILED ONE COMPLAINT FOR 5 INCIDENTS WHICH REPORTEDLY AFFECTED 3 PTS. IT IS UNCLEAR WHICH PTS EXPERIENCED PROBLEMS WITH MORE THAN ONE BLOOD TUBING SET OR WHICH DATES THOSE EVENTS TOOK PLACE. THESE SAME FACTS APPLY TO MDR NOS. 2244060-1999-00005, 00006, AND 00007.

    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 00436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention