BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13722944 · Received March 10, 2022

    Report

    Report Number
    3011581906-2022-00030
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 19, 2022
    Report Date
    March 9, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    UDI-DI
    00817170020048
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02/19/2022, A DISTRIBUTOR OF INFUTRONIX CONFIRMED WITH THE END USER THAT THE AFFECTED DEVICE WILL NOT BE RETURNED AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE COMPLAINT COULDN'T BE CONFIRMED.

    Description of Event or Problem · 0

    ON 02/19/2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT FROM AN END USER: "LEAKING THAT INDICATED A LOOSE CONNECTION BETWEEN THE PUMP TUBING AND CATHETER CONNECTOR WILL RECEIVING THERAPY AT HOME." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. 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
    1621961 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. HS-002 00817170020048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown