BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 8701072 · Received June 14, 2019

    Report

    Report Number
    3011581906-2019-00020
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 6, 2019
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020017
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED TUBING DETACHMENT ISSUE WAS CONFIRMED. THE PICTURE PROVIDED BY THE END USER SHOWED AN ADMINISTRATION SET WITH DETACHED TUBING. NO ROOT CAUSE ANALYSIS COULD BE PERFORMED, AS THE AFFECTED DEVICE WAS DISPOSED AT THE USER FACILITY.

    Description of Event or Problem · 1

    ON 06/06/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A TUBING DETACHMENT ISSUE: "IV SET LOT# IS UNKNOWN AND THE SET WILL BE RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY. TUBING DID NOT LEAK. THE TUBING BECAME ENTIRELY DETACHED FROM CASSETTE CONNECTOR SITE. I HAVE ATTACHED PHOTOS." NO PATIENT INFORMATION WAS REPORTED TO INFUTRONIX. NO INFORMATION ON THE MEDICATION USED AT THE TIME OF THE EVENT WAS AVAILABLE. ON 06/13/2019, THE DISTRIBUTOR REPORTED THAT THE USER FACILITY HAD DISPOSED THE AFFECTED DEVICE. NO INFORMATION ON THE EXPIRATION DATE OR MANUFACTURING DATE OF THE AFFECTED DEVICE WAS AVAILABLE. 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
    494287 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-001 UNKNOWN 00817170020017

    Patients

    Seq Age Sex Outcome Treatment
    1