BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15737378 · Received November 4, 2022

    Report

    Report Number
    3011581906-2022-00202
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 22, 2022
    Report Date
    November 4, 2022
    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

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEAKING FROM THE TUBING IN THE AREA OF THE CASSETTE. THE TUBING GOING FROM THE MEDICATION BAG TO THE CASSETTE BROKE APART FROM THE CONNECTION AT THE CASSETTE. "THE PUMP WAS POWERED DOWN AND THE CASSETTE POPPED OFF." THE INFUSION WAS SUSPENDED. PATIENT STATED THEY HAD SURGERY FRIDAY AND SATURDAY AFTERNOON THEY WERE HAVING DISCOMFORT SO PATIENT WAS TRYING TO GET A BOLUS. PATIENT TRIED TO PUSH THE DB BUTTON. PATIENT FINALLY TOOK THE PUMP OUT OF THE BAG TO GET A BETTER LOOK AT IT AND THAT IS WHEN THEY FELT WETNESS ON THEIR HANDS. PATIENT CALLED IN TO OUR SUPPORT LINE AND WAS GUIDED THROUGH POWERING DOWN THE PUMP AND POPPED THE CASSETTE OFF. PATIENT SAID AS SOON AS IT POPPED OFF THEY COULD TELL IT WAS WET INSIDE. WHEN PATIENT WENT TO PLACE THE PUMP BACK INTO THE CARRYING POUCH THAT IS WHEN THEY NOTICED THE POUCH WAS VERY WET. PATIENT HAS NO IDEA WHEN IT STARTED, JUST THAT THEY NOTICED IT THAT SATURDAY. THERE WAS NO ALARMING OR ERROR CODES. DEVICE OPERATOR WAS THE PATIENT. MEDICATION BEING INFUSED WAS UNKNOWN. 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
    2228158 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown