BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13060220 · Received December 22, 2021

    Report

    Report Number
    3011581906-2021-00102
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 20, 2021
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, INFUTRONIX RECEIVED THE IMAGE FOR THE AFFECTED ADMINISTRATION SET FROM THE END USER. VISUAL INSPECTION CONFIRMED THAT THE TUBING CONNECTOR ON THE DISTAL END OF THE CASSETTE MODULE WAS SNAPPED AND BROKEN. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A CLINICAL DIRECTOR OF INFUTRONIX REPORTED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008-B, LOT 2103004 BECAME DISCONNECTED FROM THE CASSETTE MUST LIKELY DUE TO THE PATIENT." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964341 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC 2103004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown