BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFUSION/FLUSH ADMINISTRATION SET

    MDR report key: 1891041 · Received June 29, 2010

    Report

    Report Number
    2025816-2010-00064
    Event Type
    Other
    Date Received
    June 29, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 22, 2010
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED SFP3259-S DEVICE SET 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 A LEAK BETWEEN THE DEVICE SETS INJECTION SITE BONDED SHUNT/TUBING CONNECTION. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WAS GENERATED. THE CAPA ACTIVITIES AND PROCESSES UTILIZE A MULTI-DISCIPLINE APPROACH TO CONDUCT MORE DETAILED AND COMPREHENSIVE DESIGN, ENGINEERING AND PRODUCTION ANALYSIS. THE CAPA ACTIVITIES ARE STRUCTURED TO IDENTIFY AND DETERMINE THE SOURCE, SCOPE, PROBABLE CAUSES AND TO IDENTIFY AND IMPLEMENT SOLUTIONS TO ADDRESS THE ISSUE(S). THE CAPA STATUS TO DATE HAS DOCUMENTED THAT THE ISSUE APPEARS TO BE ATTRIBUTABLE TO (B)(4). TESTING AND EVALUATIONS OF DUROMETER, TUBING DIMENSIONS, AND FITMENT DIMENSIONS FOR THE INVOLVED COMPONENTS TO DETERMINE HOW WALL THICKNESS, HARDNESS, AND SOLVENT APPLICATION DURING ASSEMBLY AFFECT TUBING BONDS. AFTER DETERMINING THE MAIN FACTOR(S) INVOLVED, APPROPRIATE CHANGES WILL BE IMPLEMENTED TO ADDRESS THIS BONDING ISSUE. AS AN INTERIM CORRECTIVE ACTION, (B)(4). A REVIEW OF THE MFG. LOT DATABASE RECORDS FOR THE REPORTED LOT# 1279998 (MFG. DATE 10/2008) SHOWS (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED.

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING LEAKAGE PROBLEM WITH ONE (1) SFP3259-S 82" INFUSION/FLUSH ADMIN SET W/2-WAY SC; BONDED 60" SMALLBORE EXT. THE FACILITY'S DRAFT UFMW STATES THIS IS A FOLLOW-UP TO PREVIOUS REPORT WHERE "INFUSION FLUSH ADMINISTRATION SET LEAKING AT INJECTION PORT." THE DEVICE SET WAS REMOVED AND REPLACED WITH NO FURTHER PROBLEMS. THERE WERE NO REPORTED ADVERSE PT. CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION/FLUSH ADMINISTRATION SET ADMINISTRATION TUBING SET FPA ICU MEDICAL INC. SFP3259-S 1279998

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA MEDFUSION 3500 SYRINGE PUMP