BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 13516289 · Received February 11, 2022

    Report

    Report Number
    3011581906-2022-00007
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 20, 2022
    Report Date
    March 29, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    A SERVICE PROVIDER OF INFUTRONIX PROVIDED THE EVALUATION REPORT FOR THE AFFECTED ADMINISTRATION SET ON (B)(6)2022. VISUAL INSPECTION CONFIRMED THAT THE FILTER HAD COVERED UP DRIED 5FU AND THAT INDICATES THE FILTER HAD LEAKING ISSUE. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008-B, LOT 2008004, LEAKED 5FU DURING A PATIENTS INFUSION. AREA IS UNKNOWN CURRENTLY. 5FU HAD SPILLED ON MULTIPLE PARTS OF THE SET." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. 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 (B)(6) 2022, INFUTRONIX RECEIVED A COMPLAINT FROM AN END USER: "AN ADMINISTRATION SET MODEL HS-008-B, LOT 2008004, LEAKED 5FU DURING A PATIENTS INFUSION. AREA IS UNKNOWN CURRENTLY. 5FU HAD SPILLED ON MULTIPLE PARTS OF THE SET." DEVICE OPERATOR WAS A PATIENT. MEDICATION INFUSED WAS 5FU. A PATIENT WAS INVOLVED BUT NOT HARMED. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4) MEDICAL CO. LTD.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR 3011581906-2022-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081784 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. 2008004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown