BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEXTRON MEDICAL TECHNOLOGIES, INC.

    MDR report key: 270661 · Received March 21, 2000

    Report

    Report Number
    2244060-2000-00005
    Event Type
    Other
    Date Received
    March 21, 2000
    Date of Event
    February 22, 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 TWO INCIDENTS WHERE THE BLOOD PUMP TUBING SEGMENT CRACKED DURING PT TREATMENT, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 200CC FOR EACH INCIDENT. THE CLINIC CONFIRMED THAT THE PATIENT(S)'S BLOOD TUBING WAS REPLACED WITH BLOOD TUBING FROM THE SAME LOT NUMBER WITHOUT INCIDENT. THE CLINIC ALSO REPORTED THAT NO PT INJURY OCCURRED, AND NO MEDICAL INTERVENTION WAS NECESSARY. CO WAS UNABLE TO DETERMINE IF THE TWO INCIDENTS AFFECTED THE SAME PT, AND CO WAS UNABLE TO DETERMINE THE EXTENT TO WHICH BLOOD MAY HAVE BEEN RETURNED TO THE PT. THESE SAME FACTS APPLY TO MDR NO.: 2244060-2000-00004.

    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