BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15230343 · Received August 15, 2022

    Report

    Report Number
    3011581906-2022-00107
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 15, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED ADMINISTRATION SET WAS NOT RETURNED FOR EVALUATION. A VIDEO PROVIDED BY THE END USER SHOWED MEDICATION LEAKAGE. THE REPORTED ISSUE IS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL: HS-008-B, LOT: 2103004 SET CAME DISCONNECTED FROM THE CASSETTE AND CAUSE A LEAK." DEVICE OPERATOR WAS A NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155754 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. 2103004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown