BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRON MEDICAL TECHNOLOGIES, INC.

    MDR report key: 233226 · Received July 21, 1999

    Report

    Report Number
    2244060-1999-00002
    Event Type
    Malfunction
    Date Received
    July 21, 1999
    Date of Event
    January 6, 1999
    Report Date
    July 14, 1999
    Manufacturer
    NEXTRON MEDICAL TECHNOLOGIES
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINIC ADVISED THAT BLOOD TUBING/PUMP SEGMENT FAILED AFTER 18 HOURS OF USE. THE PT WAS GIVEN ONE UNIT OF BLOOD AFTER THE INCIDENT. THE USER FACILITY WAS UNABLE TO PROVIDE ENOUGH INFO TO DETERMINE IF THE PT WAS THE SAME AS DESCRIBED IF THE PT WAS THE SAME AS DESCRIBED IN MDR NO. 2244060-1999-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXTRON MEDICAL TECHNOLOGIES, INC. BLOOD TUBING SET (DHZ0005 AVF) FJK NEXTRON MEDICAL TECHNOLOGIES 505/PAN 00260

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention