BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13673574 · Received March 4, 2022

    Report

    Report Number
    3011581906-2022-00025
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 9, 2022
    Report Date
    April 29, 2022
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    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 AFFECTED 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 04/22/2022. VISUAL INSPECTION CONFIRMED THAT THE SILICON-PVC ADAPTOR 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, WAS LEAKING DURING AN INFUSION, AND IT HAD GOTTEN ON THE SCREEN OF THE PUMP." THE END USER WAS UNABLE TO LOCATE THE ORIGIN OF THE LEAK, BUT THE DRUG HAD SEEPED ONTO THE PUMP. 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.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2022-00025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597300 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC 2103004

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female