BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRFIT

    MDR report key: 10159521 · Received June 16, 2020

    Report

    Report Number
    3012307300-2020-05985
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    May 18, 2020
    Report Date
    October 16, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    UDI-DI
    10610586044007
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP . SAMPLES RETURNED P/N 21-7600-24 MANUFACTURED WITH THE LOT 3883724 IN NOT ITS ORIGINAL PACKAGING. VISUAL INSPECTIONS UNDER PROCEDURE ?VISUAL INSPECTION? MD01-003 REV. 102 REVEALED NO DISCREPANCIES. WHEN FUNCTIONAL TESTING WAS DOWN TO INFUSE WATER THE COMPLAINT WAS VERIFIED. ALL MANUFACTURING PROCESS WAS REVIEWED . ROOT CAUSE INVESTIGATION AND CORRECTIVE ACTIONS WILL BE FOLLOW BY CAPA PROCESS, THROUGH CAPA-000713 OPEN ON SEPTEMBER 22ND 2020. BY THE DATE THAT THIS INVESTIGATION REPORT IS DOCUMENTED CAPA-000713 IS UNDER INVESTIGATION PHASE. THE EXPECTED DUE DATE OF THIS INVESTIGATION PHASE IS NOVEMBER 23RD.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS, THE CUSTOMER NOTICED MEDICAL FLUID LEAKING FROM WHERE THE CASSETTE'S CONNECTOR AND EXTENSION TUBE CONNECTED. NO REPORTED ADVERSE EFFECTS OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623754 NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS MEDICAL ASD, INC. 21-7600-24 3883724 10610586044007

    Patients

    Seq Age Sex Outcome Treatment
    1