BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13417683 · Received February 1, 2022

    Report

    Report Number
    3011581906-2022-00005
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 13, 2022
    Report Date
    April 15, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE DEVICE TO BE RETURNED FOR EVALUATION

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED ADMINISTRATION SET ON 04/15/2022. VISUAL INSPECTION CONFIRMED THAT THE SILICON-PVC CONNECTOR ON THE PROXIMAL END OF THE CASSETTE MODULE WAS SNAPPED AND BROKEN. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008-B, LOT 2103004 LEAKED ALL INTO THE BAG AND HARD-SHELL. AREA OF THE LEAK IS UNKNOWN, WILL ONLY BE ABLE TO CONFIRM WHEN THE SET IS RETURNED. THIS OCCURRED DURING A 46 HOUR INFUSION." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2022-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447292 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. 2103004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown