BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13643248 · Received March 1, 2022

    Report

    Report Number
    3011581906-2022-00016
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    January 20, 2022
    Report Date
    February 28, 2022
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020024
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, INFUTRONIX CONFIRMED WITH THE END USER THAT THE AFFECTED DEVICE WAS DISCARDED BY THE END USER AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-003, LOT 2004017 WAS LEAKING FROMA A SMALL HOLE IN THE TUBING." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153412 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-003 2004017 00817170020024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown