BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15539835 · Received October 4, 2022

    Report

    Report Number
    3011581906-2022-00184
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 4, 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

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. RETURN OF THE DEVICE WAS REQUESTED, BUT THE REPORTER CONFIRMED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF A PATIENT: "THE TUBING CONNECTED TO THE PUMP WAS LEAKING BUT WAS UNABLE TO PINPOINT OR DETERMINE THE EXACT LOCATION OR CAUSE OF THE LEAK." EVENT OCCURRED DURING INFUSION. DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING 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
    2506851 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