BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 11174577 · Received January 14, 2021

    Report

    Report Number
    3011581906-2020-00130
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    November 16, 2020
    Report Date
    January 14, 2021
    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 · 1

    ON (B)(6) 2020 , INFUTRONIX CONFIRMED WITH THE DISTRIBUTOR THAT THE AFFECTED DEVICE WAS NEVER RETURNED FOR EVALUATION AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THIS MDR IS A RESULT OF COMPLAINT REMEDIATION EFFORT.

    Description of Event or Problem · 1

    ON (B)(6) 2020 , A DISTRIBUTOR OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER. PATIENT REPORTED, "THAT AN ADMINISTRATION SET HAD LEAKING AT THE CONNECTION AT THE CATHETER AND PUMP TUBING." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS UNKNOWN. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE DEVICE IS PODO XINGDA ((B)(4) ) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69094 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1