BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13982630 · Received April 1, 2022

    Report

    Report Number
    3011581906-2022-00041
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 9, 2022
    Report Date
    April 1, 2022
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED THE IMAGE OF THE AFFECTED DEVICE FROM THE END USER. VISUAL INSPECTION CONFIRMED THE SILICON-PVC ADAPTOR WAS BROKEN AT THE DISTAL END OF THE CASSETTE. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "MEDICATION WAS LEAKING." "THE MEDICATION HAD LEAKED AND SOAKED THE ENTIRE BAG." DEVICE OPERATOR WAS A PATIENT. MEDICATION INVOLVED ARE ADRIAMYCIN, VP16, AND VINCRISTINE. 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
    1839224 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC 2106007

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female