BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    MDR report key: 8096881 · Received November 21, 2018

    Report

    Report Number
    3011581906-2018-00032
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 16, 2018
    Report Date
    November 16, 2018
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020031
    PMA / PMN Number
    K140783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX RECEIVED THE EVALUATION REPORT FROM THE SERVICE PROVIDER ON (B)(6)2019. THE REPORTED LEAKING ISSUE WAS CONFIRMED. DRIED WHITE SUBSTANCE CONSIDERED TO BE 5FU WAS OBSERVED AT THE DISTAL CONNECTOR SITE OF THE ADMINISTRATION SET CASSETTE. DETAILS OF THE TESTING CAN BE FOUND IN THE ATTACHED REPORT. CORRECTION: THERE WAS A TYPO IN SECTION G5:PMA/510(K) OF THE INITIAL SUBMISSION. THE CORRECTED 510 (K) NUMBER SHOULD BE K140783. - ATTACHMENT: [COMPLAINT-(B)(4). EVALUATION REPORT.PDF]

    Description of Event or Problem · 0

    THIS IS THE FOLLOW UP REPORT FOR THE INITIALLY SUBMITTED MDR (3011581906-2018-00032).

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE IS NOT YET RETURNED TO THE DISTRIBUTOR OF INFUTRONIX.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED AN ADMINISTRATION SET LEAKING ISSUE DISCOVERED AT USER FACILITY TO INFUTRONIX ON (B)(4) 2018. MEDICATION INFUSED AT THE TIME OF EVENT WAS 5FU. NO PATIENT INJURY OR HARM OCCURED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934015 ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX) IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-004 1805002 00817170020031

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR