BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 16150452 · Received January 12, 2023

    Report

    Report Number
    3011581906-2022-00264
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 12, 2023
    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

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT, WHO REPORTED A LEAK WITH AN ADMINISTRATION SET. DEVICE OPERATOR WAS A PATIENT. MEDICATION BEING INFUSED WAS 5FU. NO PATIENT INJURY REPORTED. 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
    1132440 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown