BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFUSION ADMINISTRATION SET

    MDR report key: 1891042 · Received June 29, 2010

    Report

    Report Number
    2025816-2010-00067
    Event Type
    Other
    Date Received
    June 29, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING LEAKAGE PROBLEM WITH ONE (1) SFP3259-S 82" INFUSION/FLUSH ADMIN SET W/2-WAY SC; BONDED 60" SMALLBORE EXTENSION SETS. THE DEVICE SET WAS REMOVED AND REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ONE USED SFP3259-S DEVICE SET, LOT# 997759 WAS RETURNED TO THE MFR FOR TESTING AND ANALYSIS. THE MFR'S DEVICE/COMPLAINT ANALYSIS IS SUMMARIZED BELOW: FUNCTIONAL/PERFORMANCE TESTS WERE PERFORMED. THE RESULTS CONFIRMED LEAKAGE AT THE SFP3259-S MALE LUER SLIP/STOPCOCK FEMALE LUER BONDED CONNECTION. THE ROOT CAUSE WAS DUE TO A POOR QUALITY BOND. A REVIEW OF THE MFR LOT DATABASE RECORDS FOR LOT# 997759 (MFR DATE 11/2007) SHOWS (B)(4) UNITS WERE MFG TESTED, INSPECTED AND RELEASED. A CORRECTIVE ACTION REQUEST (CAR) WAS GENERATED. THE CAR ACTIVITIES AND PROCESSES ARE STRUCTURED TO IDENTIFY AND DETERMINE THE SOURCE, SCOPE, PROBABLE CAUSES AND TO IDENTIFY AND IMPLEMENT SOLUTIONS TO ADDRESS THE ISSUES. ALTHOUGH NOT ALWAYS REPEATABLE, THE CAR ENGINEERING ANALYSIS DOCUMENTED THAT (B)(4). THE ONE (1) RETURNED SFP3259-S REFLECTED LOT# 997759 (MFR 11/2007). THIS LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS COMPONENT LUER CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION ADMINISTRATION SET ADMINISTRATION TUBING SET FPA ICU MEDICAL, INC. SFP3259-S 997759

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDFUSION 3500 SYRINGE PUMP