BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13673685 · Received March 4, 2022

    Report

    Report Number
    3011581906-2022-00026
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 2, 2022
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020031
    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 END USER'S RESPONSE REGARDING THE DEVICE RETURN STATUS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: A MEDICATION LEAK AT THE FILTER. THE END USER SAID HE COULD SEE WHITE CRYSTALS AROUND THE FILTER. DEVICE OPERATOR WAS A PATIENT. 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
    2569073 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-004 00817170020031

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male