BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 16072046 · Received December 29, 2022

    Report

    Report Number
    3011581906-2022-00257
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 14, 2022
    Report Date
    December 29, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL, WHO REPORTED TUBING BROKE OFF THE CASSETTE. DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS 5FU. NO PATIENT INJURY REPORTED. 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
    2825540 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown