BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 11159382 · Received January 13, 2021

    Report

    Report Number
    3011581906-2020-00115
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 5, 2019
    Report Date
    January 11, 2021
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020048
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/17/2020 INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THIS MDR IS A RESULT OF COMPLAINT REMEDIATION EFFORT.

    Description of Event or Problem · 1

    ON 12/17/2020 A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "PATIENT'S DAUGHTER REPORTED THAT THE PATIENT ROLLED OVER TOO FAST AND BROKE THE TUBING BY THE LUER LOCK CONNECTOR. THE TUBING GLUE CAME OUT FROM THE LUER LOCK SO THEY CANNOT RECONNECT IT." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. 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
    62908 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-002 UNKNOWN 00817170020048

    Patients

    Seq Age Sex Outcome Treatment
    1