BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13588683 · Received February 23, 2022

    Report

    Report Number
    3011581906-2022-00012
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 22, 2022
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020048
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION.THE REPORTED BROKE TUBING ISSUE WAS CAUSED BY THE END USER DROPPED THE PUMP ON THE GROUND.

    Additional Manufacturer Narrative · 0

    ON 02/01/2021, INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION.THE REPORTED BROKE TUBING ISSUE WAS CAUSED BY THE END USER DROPPED THE PUMP ON THE GROUND.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THEY ACCIDENTALLY DROPPED THE PUMP ON THE GROUND AND THE TUBING BROKE FROM THE DISTAL END OF THE PUMP." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(6) MEDICAL CO. LTD.

    Description of Event or Problem · 0

    ON 02/01/2022, A DISTRIBUTOR OF INFUTRONIX REPORTED A COMPLAINT ON BEHALF OF AN END USER: "THEY ACCIDENTALLY DROPPED THE PUMP ON THE GROUND AND THE TUBING BROKE FROM THE DISTAL END OF THE PUMP." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. 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
    225238 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-002 00817170020048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown