BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15639554 · Received October 20, 2022

    Report

    Report Number
    3011581906-2022-00196
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 5, 2022
    Report Date
    October 13, 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

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, AND PRODUCT 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 HAS BEEN DISCARDED.

    Description of Event or Problem · 0

    A DISTRIBUTOR OF INFUTRONIX RECEIVED A COMPLAINT FROM A PATIENT, WHO REPORTED A LEAKING ADMINSTRATION SET. PATIENT WAS INSTRUCTED TO TURN OFF THE PUMP, BUT REFUSED TO DO SO. HEALTHCARE PROFESSIONAL WAS CONTACTED, AND THEY INDICATED THE LEAK WAS "AROUND THE FILTER". DEVICE OPERATOR WAS THE PATIENT. MEDICATION BEING INFUSED IS 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
    2494830 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. 2203016

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female