BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 12202507 · Received July 21, 2021

    Report

    Report Number
    3011581906-2021-00051
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 19, 2021
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021 INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS DISCARDED AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "AN ADMINISTRATION SET MODEL HS-008 LOT 2008005 SET WAS LEAKING AT THE FILTER, IT HAD LEAKED OUT AND SOAKED THE ENTIRE BAG." 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)(4) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100304 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-008 2008005

    Patients

    Seq Age Sex Outcome Treatment
    1