BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEXTRON MEDICAL TECHNOLOGIES, INC.

    MDR report key: 275695 · Received April 27, 2000

    Report

    Report Number
    2244060-2000-00010
    Event Type
    Other
    Date Received
    April 27, 2000
    Date of Event
    April 19, 2000
    Report Date
    April 27, 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 CUSTOMER REPORTED 3 INCIDENTS WHERE THE BLOOD PUMP TUBING SEGMENT SPLIT DURING PT TREATMENT, RESULTING IN A BLOOD LOSS OF APPROXIMATELY 250CC FOR EACH INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE BLOOD TUBING WAS IN USE FOR OVER 24 HOURS (NOTE: THE INSTRUCTIONS FOR USE INCLUDED WITH EACH BLOOD TUBING SET RECOMMEND CHANGING THE BLOOD TUBING EVERY 24 HOURS). THE CUSTOMER ALSO INDICATED THAT TREATMENT WAS CONTINUED WITH NEW TUBING WITHOUT INCIDENT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THESE SAME FACTS APPLY TO MDR NOS. 2244060-2000-00008 AND 00009.

    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