BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEONATAL TRANSPAC IV MONITORING KITS

    MDR report key: 2411042 · Received December 22, 2011

    Report

    Report Number
    2025816-2011-00030
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DATABASE AND RECORD ANALYSIS: A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST#/SIMILAR PROBLEM RECORDED NO ADDITIONAL REPORTS OR INVESTIGATIONS CONFIRMING A MFG OR DESIGN DEFECT. A REVIEW OF THE MFG LOT DATABASE FOR THE ONE IDENTIFIED SUSPECT LOT# 1903633 (MFG. DATE 05/2010) SHOWS (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. CONCLUSION: THE VISUAL ANALYSIS OF THE RETURNED MONITORING KITS COMPONENTRY CONFIRMED EXTENSIVE DAMAGES. THE ROOT CAUSE(S) OF THE COMPONENT DAMAGES APPEAR TO BE THE RESULT OF UNINTENDED FORCE/USAGE. AS THESE ARE PURCHASED COMPONENTS, THE COMPONENT VENDOR HAS BEEN NOTIFIED. THIS REPORT AND THE ASSOCIATED INFORMATION HAVE BEEN ENTERED IN THE MFR'S DATABASE FOR ANALYSIS AND TRENDING.

    Description of Event or Problem · 1

    (B)(4) REPORT RECEIVED REPORTING BREAKAGE PROBLEMS WITH APPROX TEN (10) 42586-05 24" NEONATAL TRANSPAC IV MTG. KITS, LOT# UNKNOWN. IT WAS REPORTED THAT DURING SET-UPS, CLINICIANS REPORT "OPENED SEVERAL KITS YESTERDAY AND WHEN TRYING TO REMOVE ONE OF THE STOPCOCKS, A PIECE OF IT CRACKED OFF. THERE WAS NO VISUAL INDICATION THAT THE DEVICES WERE BROKEN OR CRACKED BEFORE USING THEM AND THE PACKAGING WAS INTACT. STAFF DID NOT APPLY EXTRA FORCE TO REMOVE THE STOPCOCKS. THE KITS ARE STORED ON SHELVES IN THE UNIT. THEIR CONTAINERS DID NOT APPEAR TO HAVE BEEN CRUSHED OR DAMAGED IN ANY WAY. TEN KITS WERE AFFECTED." THE MFR RECEIVED TWO (2) PARTIAL 42586-05 KIT COMPONENTS (3-WAY STOPCOCKS) IDENTIFIED AS LOT# 1903633. MFR'S COMPLAINT INVESTIGATION: VISUAL ANALYSIS RECORDED COMPONENT DAMAGES ON BOTH OF THE RETURNED 3-WAY STOPCOCK SUB ASSEMBLIES. THE REPORT NOTED THE RETURNED SAMPLE #1 3-WAY STOPCOCK MALE LUER TAPER WAS MANGLED/TWISTED/DAMAGED. THE RETURNED SAMPLE #2 3-WAY STOPCOCK MALE LUER TIP WAS LODGED INTO THE FEMALE LUER OPENING. DIMENSIONAL EVALUATIONS WERE PERFORMED. THE RESULTS RECORDED THE COMPONENTS FEMALE LUER TAPERS PASSED ISO 594-1 GO/NO GO GAUGE. IT WAS NOTED THAT THE FEMALE LUER ON SAMPLE#2 COULD NOT BE MEASURED DUE TO THE RECEIVED CONDITION (MALE LUER LODGED INSIDE). THE RETURNED COMPONENTS MALE LUER TAPERS PASSED ISO 594-1 GO/NO GO GAUGE. IT WAS NOTED THAT DUE TO THE DAMAGE ON SAMPLE# 1 MALE LUER, VALID DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. THE REPORT ALSO NOTED ALL FEMALE LUER LOCKS PASSED ISO 594-2 GO/NO GO GAUGE AS WELL AS THE MALE LUER LOCKS PASSED ISO 594-2 GO/NO GO GAUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEONATAL TRANSPAC IV MONITORING KITS NEONATAL TRANSPAC IV MONITORING KITS DRS ICU MEDICAL, INC. 42586-05 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1