BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15451274 · Received September 19, 2022

    Report

    Report Number
    3011581906-2022-00132
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Report Date
    September 19, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    ON (B)(6)2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "WE HAD 2 TUBING/PUMP MALFUNCTIONS LAST WEEK WHERE THE TUBING CAME UNATTACHED SOAKING THE PUMPS. WE HAD RECEIVED A NEW BATCH OF TUBING A COUPLE OF WEEKS AGO BUT IT IS STILL HAPPENING THE NEW LOT THAT WAS SENT TO US #2203016 EXP 2025-03-24" DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. 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
    223344 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. 2203016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown