BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 16646439 · Received March 30, 2023

    Report

    Report Number
    3011581906-2023-00027
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 30, 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

    RETURN OF THE DEVICE WAS REQUESTED, BUT THE REPORTER CONFIRMED THAT THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT, WHO REPORTED THEY HAD A LEAK THEY HAD DISCOVERED ON THEIR BAG. THEY STATED THEY BAG WAS SOAKED AND THEY NOTICED A WHITE SUBSTANCE COVERING IT. PUMP WAS POWERED OFF, LINE WAS CLAMPED. HEALTHCARE PROFESSIONAL (HCP) REPORTED THE PATIENT CLEANED UP THEMSELVES AND AREA WITH SOAP AND WATER. PATIENT THEN WRAPPED THE BLACK POUCH AND THE INFUSION PUMP ITSELF IN PLASTIC. "THE NURSE ASSESSING THE PATIENT UPON THEIR RETURN TO THE CLINIC 2 DAYS LATER COULD NOT FIND ANY LEAKS OR CRACKS IN THE TUBING. UNABLE TO KNOW IF ANY AIR ENTERED THE LINE." "APPROXIMATELY 49 HOURS INTO THE INFUSION. THE PATIENT WAS HOOKED TO THE PUMP ON (B)(6) 2023 AT 1630." THE REPORTED LEAK WAS FIRST REPORTED TO THE ON-CALL NURSE ON (B)(6) 2023 AT APPROXIMATELY 1800. HEALTHCARE PROFESSIONAL ALSO REPORTED "I AM 99% SURE THAT THIS WAS NOT A TUBING OR PUMP ISSUE. THIS PATIENT IS EXTREMELY NONCOMPLIANT AND HAD TAKEN THE PUMP AND MEDICATION BAG OUT OF THE POUCH WEDNESDAY EVENING AND LIKELY DROPPED IT. PATIENT DID NOT COME IN YESTERDAY AS THEY WERE INSTRUCTED TO DO. WHEN THEY CAME THIS MORNING FOR PUMP DISCONNECT, THEY HAD IT CLAMPED AND OFF. THE INFUSION NURSE CHECKED BOTH THE TUBING AND THE BAG AND DID NOT FIND ANY VISIBLE LEAKS. THEY DID SEE SOME DRIED WHITE RESIDUE FROM THE 5FU BUT COULD NOT CURRENTLY FIND ANY CURRENT LEAKS WHATSOEVER.". DEVICE OPERATOR WAS A PATIENT. 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
    177054 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown