BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL MONITORING KIT

    MDR report key: 4994608 · Received August 10, 2015

    Report

    Report Number
    2025816-2015-00094
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    February 25, 2015
    Report Date
    March 19, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: METHOD: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT #2963371 (MFG. 11/2014) SHOWED (B)(4) UNITS WERE MFG. , TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST #, LOT# AND SIMILAR COMPONENT ISSUE RECORDED NO ADDITIONAL REPORTS. FINDINGS: THE INVOLVED (B)(4) DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE(S) OF THE REPORTED EVENT/PRODUCT ISSUE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS: THE RETURNED 46094-31 MTG. KIT AND 10ML SYRINGE WERE PRIMED AND PRESSURE TESTED. THE RESULTS RECORDED LEAKAGE ORIGINATING FROM THE BOTTOM OF THE STOPCOCK. FURTHER ENGINEERING ANALYSIS DETERMINED THE CAUSE OF THIS FAILURE WAS DUE TO INSUFFICIENT SEAL BETWEEN THE ROTARY SWITCH AND BODY COMPONENTS. THE STOPCOCK IS A PURCHASED COMPONENT. ICU MEDICAL INITIATED A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND PROCESSED THE STOPCOCK TO THE VENDOR FOR ADDITIONAL INVESTIGATION AND ANALYSIS. ALTHOUGH THE SUPPLIER INVESTIGATION AND ANALYSIS OF THIS ISSUE IS STILL IN PROGRESS, THEY HAVE NOT YET IDENTIFIED A SPECIFIC ROOT CAUSE. HEIGHTENED INSPECTIONS HAVE BEEN INITIATED. TREND AND LOT RECORD REVIEWS: A REVIEW OF SUPPLIER COMPONENT/LOT HISTORY RECORDS AND TREND REPORTS SHOWED NO ADVERSE TRENDS. FINDINGS: THE REPORTED PRODUCT ISSUE WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO AN INSUFFICIENT SEAL WITHIN THE STOPCOCK INTERNAL COMPONENTS. ICU MEDICAL IS WORKING WITH THE COMPONENT SUPPLIER TO ENSURE APPROPRIATE ACTIONS ARE IDENTIFIED AND IMPLEMENTED.

    Description of Event or Problem · 1

    MAUDE REPORT RECEIVED CONCERNING LEAKAGE ISSUE WITH USE OF (B)(4) NEONATAL MTG. KIT. (B)(4) DESCRIBES THE EVENT AS FOLLOWS "... PT. REQUIRED UAC LINE FOR FLUIDS AND MONITORING. RN NOTICED THE UAC LINE WAS LEAKING FLUIDS AT THE STOPCOCK. LINE EXAMINED AND FOUND TO BE DEFECTIVE. IV TUBING AND FLUIDS WERE REPLACED. NO PATIENT HARM." FOLLOW UP WITH THE FACILITY FOR ADDITIONAL RELEVANT SET-UP/USAGE INFORMATION AND DEVICE RETURN STATUS AS OF THE DATE OF THIS REPORT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: DEVICE RETURN: ONE USED 46094-31 NEONATAL MTG. KIT ATTACHED TO A 10ML SYRINGE. THIS IS THE MFGER'S FOLLOW UP REPORT TO PROVIDE THE DEVICE RETURN INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521432 NEONATAL MONITORING KIT MONITORING KIT DRS ICU MEDICAL, INC. 46094-31 2963371

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA