BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEXTRON MEDICAL TECHNOLOGIES, INC.

    MDR report key: 270696 · Received March 21, 2000

    Report

    Report Number
    2244060-2000-00001
    Event Type
    Other
    Date Received
    March 21, 2000
    Date of Event
    March 1, 2000
    Report Date
    March 21, 2000
    Manufacturer
    NEXTRON MEDICAL TECHNOLOGIES
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLINIC REPORTED THREE INCIDENTS WHERE THE BLOOD PUMP TUBING SEGMENT CRACKED DURING PT TREATMENT, RESULTING IN A BLOOD LEAK OF APPROXIMATELY 250CC FOR EACH INCIDENT. THE CLINIC ALSO REPORTED THAT NO PT INJURY OCCURRED, AND NO MEDICAL INTERVENTION WAS NECESSARY. CO WAS UNABLE TO DETERMINE IF THE THREE INCIDENTS REPORTED AFFECTED THE SAME PT, AND CO WAS UNABLE TO DETERMINE THE EXTENT TO WHICH BLOOD MAY HAVE BEEN RETURNED TO THE PT(S). THESE SAME FACTS APPLY TO MDR NOS.: 2244060-2000-00002 AND 00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXTRON MEDICAL TECHNOLOGIES, INC. BLOOD TUBING SET FJK NEXTRON MEDICAL TECHNOLOGIES HT-HF-505/PAN 99G200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other