BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 11704257 · Received April 21, 2021

    Report

    Report Number
    3011581906-2021-00022
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 19, 2021
    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 · 1

    ON 03/30/2021, INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON 03/30/2021, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "SHE WAS USING THE BATHROOM AND THE NOTICED A SMALL LEAK CAME OUT FROM SOMEWHERE AT THE BLACK POUCH, BUT SHE DOESN'T KNOW WHERE. PATIENT REINFORCED A FOIL AT THE MED BAG, CHECKED THE CATHETER INSERTION SITE, THE TUBING AND BOTH SIDES OF THE CASSETTE. WE WERE UNABLE TO FIND THE LOCATION THE LIQUID CAME OUT FROM." 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 (B)(4) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601055 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-002 00817170020048

    Patients

    Seq Age Sex Outcome Treatment
    1