BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13673489 · Received March 4, 2022

    Report

    Report Number
    3011581906-2022-00023
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 9, 2022
    Report Date
    August 24, 2022
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    A VISUAL INPECTION AND A LEAKING TEST WERE PERFORMED FOR THE AFFECTED SET. NO SIGNS OF LEAKAGE OR DAMAGE WERE NOTICEABLE. THE SET MEETS PASSING CRITERIA. THE CUSTOMER PROVIDED AN IMAGE SHOWING FLUID SPILL INSIDE THE HARD SHELL AND LEAKAGE ORIGINATING FROM THE MEDICATION BAG, WHICH IS NOT AN INFUTRONIX PRODUCT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM THE REGISTERED NURSE OF THE USER FACILITY: "AN ADMINISTRATION SET MODEL HS-008-B, LOT 2103004, PATIENT CAME BACK WITH A PUMP AND SET UP THAT EXPERIENCED A LEAK DURING INFUSION." IT IS UNKNOWN WHERE THE LEAK IS COMING FROM. DEVICE OPERATOR WAS A NURSE. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2022-00023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215373 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC 2103004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown