BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15739090 · Received November 4, 2022

    Report

    Report Number
    3011581906-2022-00198
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Report Date
    November 4, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED "LEAKING AROUND THE 0.2 MICRON FILTER ATTACHMENTS". EVENT OCCURRED DURING INFUSION. DEVICE OPERATOR WAS THE 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
    2178290 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. 2007002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown