BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITORING KIT

    MDR report key: 5643613 · Received May 10, 2016

    Report

    Report Number
    2025816-2016-00035
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 19, 2016
    Report Date
    May 9, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT REVIEW: A REVIEW OF LOT#3202037 (B)(4). VISUAL RECEIPT ANALYSIS: 04/25/2016 - RECEIVED ONE (1) USED 46010-34, MONITORING KIT, SUSPECT LOT# 3202037. ONE (1) USED 3ML SALINE FLUSH SYRINGE. BLOOD WAS VISIBLE IN THE DISTAL PRESSURE TUBING. A LEAK WAS CONFIRMED AT THE BONDING SITE OF THE PRESSURE TUBING AND THE DISTAL MALE LUER THAT IS CONNECTED TO THE DISTAL STOPCOCK. FUNCTIONAL TESTING: THE UNIT WAS PRESSURE TESTED. LEAKING WAS OBSERVED FROM THE TUBING TO MALE LUER BOND ON THE DISTAL STOPCOCK. UNDER MAGNIFICATION THE TUBING WAS OBSERVED TO BE PARTIALLY CRACKED. ANALYSIS SUMMARY: ROOT CAUSE IS UNDETERMINED. THE INITIAL ENGINEERING EFFORTS AND TEAM INVESTIGATIONS OF THIS COMPONENT ASSEMBLY BODING PROCESSES RECORDED MIXED FINDINGS THAT WERE INCONCLUSIVE. ADDITIONAL INVESTIGATION ACTIVITIES AND ENGINEERING EFFORTS ARE IN PROGRESS. A MULTI-DISCIPLINE CONTINUOUS IMPROVEMENT TEAM HAS BEEN FORMED TO REVIEW AND CHALLENGE THE APPLICABLE DESIGN, MATERIALS, AND INVOLVED MANUFACTURING/EQUIPMENT PROCESSES. AS AN INTERIM MEASURE HEIGHTENED INSPECTIONS HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE 46010-34, MONITORING KIT, SUSPECT LOT# 3202037 (MFD 03/2016). REPORT STATES, "TRANSDUCER TUBING BROKEN AND/OR LEAKING. BLOOD NOTED DRIPPING FROM STOPCOCK SITE CLOSEST TO THE PATIENT. WAVEFORM DAMPENED AND ARTERIAL LINE ALARMING ON THE MONITOR. MINIMAL BLOOD LOSS." NO SERIOUS PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298931 MONITORING KIT MONITORING KIT DRS ICU MEDICAL, INC. 46010-34 3202037

    Patients

    Seq Age Sex Outcome Treatment
    1