BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 12268917 · Received August 3, 2021

    Report

    Report Number
    3011581906-2021-00055
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 9, 2021
    Report Date
    August 2, 2021
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/13/2021, A COMPLAINT HANDLING SPECIALIST OF INFUTRONIX CONFIRMED WITH THE USER FACILITY THAT THE AFFECTED DEVICE HAS BEEN DISCARDED AND THEREFORE NO ROOT CAUSE COULD BE ESTABLISHED. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON 07/13/2021, A COMPLAINT HANDLING SPECIALIST OF INFUTRONIX REPORTED AN ISSUE ON BEHALF OF AN END USER: "AN ADMINISTRATION SET MODEL HS-008 LOT N/A SET LEAKED AND IT SOAKED THE ENTIRE BAG. EXACT LOCATION OF LEAK IS UNKNOWN BY THE CUSTOMER. THEY DID NOT SEE WHERE IT WAS COMING FROM. THEY ALSO CONFIRMED TO ME THAT THE SET WILL NOT BE RETURNED, THEY WERE ALREADY DISCARDED." DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS 5FU. 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
    1166078 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA HS-008

    Patients

    Seq Age Sex Outcome Treatment
    1