BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 16117603 · Received January 6, 2023

    Report

    Report Number
    3011581906-2022-00262
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 17, 2022
    Report Date
    January 6, 2023
    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 · 0

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. RETURN OF THE DEVICE WAS REQUESTED, BUT THE REPORTER CONFIRMED THAT THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT, WHO REPORTED THERE WAS A LEAK IN THE TUBING. THE TUBING WAS CLAMPED, AND THE PUMP POWERED OFF. THE LEAK WAS LOCATED BELOW THE CLAMP. PATIENT STATED "I WAS WORKING ON MY TRUCK AND TRAILER AND IT GOT PINCHED". PATIENT RETURNED TO ER, TUBING WAS DISCARDED. 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
    1534911 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown