BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 12817879 · Received November 15, 2021

    Report

    Report Number
    3011581906-2021-00086
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 25, 2021
    Report Date
    December 6, 2021
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020031
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED ADMINISTRATION SET ON (B)(6) 2021. VISUAL INSPECTION CONFIRMED THAT THE SET HAD A LEAK AT THE FILTER AS THERE WAS DRIED UP MEDICATION COVERING THE FILTER. THE REPORTED ISSUE WAS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED. PLEASE NOTE: FOR THE INVESTIGATION FINDINGS CODE, INFUTRONIX LLC DECIDED TO SELECT 4247 APPROPRIATE TERM/CODE NOT AVAILABLE, SUGGEST ADDING THE PREFERRED TERM "ROOT CAUSE IS NOT IDENTIFIED." TO THE FUTURE CODE TABLE."

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2021-00086.

    Description of Event or Problem · 0

    ON (B)(6) 2021, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-004 LOT 2106005 SET WAS LEAKING AT THE FILTER." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711916 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-004 2106005 00817170020031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown