BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFUSION ADMINISTRATION SET

    MDR report key: 1891020 · Received June 29, 2010

    Report

    Report Number
    2025816-2010-00062
    Event Type
    Other
    Date Received
    June 29, 2010
    Report Date
    May 3, 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

    ONE USED SFP3259-S DEVICE SET, LOT# 970562, 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 MFG LOT DATABASE RECORDS FOR LOT# 970652 (MFG. DATE 09/2007) 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 IT WAS POSSIBLE FOR THE SETS MALE LUER SLIP TO SLIDE OUT OF THE FEMALE LUER DURING THE BONDING PROCESS. FURTHER TESTING, ANALYSIS AND VALIDATIONS SHOWED THAT BY CHANGING THE MALE LUER SLIP MATERIAL FROM A RIGID PVC TO A SEMI RIGID PVC RESULTED IN A BETTER QUALITY BOND. CURRENT BUILD REFLECTS THIS CHANGE TO THIS SUB ASSEMBLY. THE ONE (1) RETURNED SFP3259-S REFLECTED LOT# 970562 (MFG. 09/2007). THIS LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS COMPONENT LUER CHANGE.

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING INTERMITTENT LEAKAGE PROBLEMS WITH (EST. QTY.) FIVE (5) SFP3259-S 82" INFUSION/FLUSH ADMIN SET W/2-WAY SC; BONDED 60" SMALLBORE EXT SETS. THE REPORT STATES "MULTIPLE LOT NUMBERS EXHIBITING LEAKAGE AT VARIOUS SITES ON THE TUBING SETS." DETECTED DURING SET-UPS, NO DIRECT PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MEDFUSION 3500 SYRINGE PUMP