BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 11158902 · Received January 13, 2021

    Report

    Report Number
    3011581906-2020-00110
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    August 7, 2020
    Report Date
    January 11, 2021
    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 · 1

    ON (B)(6)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 (B)(6) 2020, A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "PATIENT REPORTED HER YELLOW CONNECTOR BECAME DISCONNECTED FROM THE TUBING." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55896 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1