BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 11798417 · Received May 10, 2021

    Report

    Report Number
    3011581906-2021-00021
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 7, 2021
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020031
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED ADMINISTRATION SET ON (B)(6) 2021. VISUAL INSPECTION CONFIRMED THAT THE TUBING CONNECTOR ON THE PROXIMAL END OF THE CASSETTE MODULE WAS SNAPPED AND BROKEN. THE TUBING WAS COMPLETELY SEPARATED FROM THE CASSETTE. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2021-00021.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "AN ADMINISTRATION SET MODEL HS-004 LOT IS UNKNOWN AT THE MOMENT. SET BECAME DISCONNECTED AT THE SIDE OF THE CASSETTE. TINA RECEIVED A LABEL AND CONFIRMED SHE WILL SEND OUT THE SET TO US (B)(6) 2021. AWAITING LOT# CURRENTLY. PICTURES WERE SENT SHOWING THE ISSUE." DEVICE OPERATOR WAS A REGISTERED NURSE. 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
    694026 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-004 00817170020031

    Patients

    Seq Age Sex Outcome Treatment
    1