BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 2411061 · Received December 22, 2011

    Report

    Report Number
    2025816-2011-00072
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 4, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION: ONE (1) USED, PARTIAL (B)(4), 60" TRANSPAC IV MTO KIT W/SAFESET WAS RETURNED. PRE AND POST DECONTAMINATION INSPECTION DOCUMENTS EXTENSIVE COMPONENT DAMAGES/BREAKAGES. THE ENGINEERING TESTING AND EVALUATIONS OF THE COMPONENT CONDITIONS SHOW THE DEVICE/COMPONENTS WERE SUBJECTED TO A COMBINATION OF INCORRECT USAGE/TECHNIQUE AND EXTREME FORCE. RECORD REVIEW: A REVIEW OF THE MANUFACTURING LOT DATABASE FOR LOT NUMBER 2233653 (MFG. DATE 03/2011) SHOWS 1740 UNITS WERE MFG. TESTED, INSPECTED AND RELEASED. CONCLUSION: THE EXACT CAUSE(S) OF THE REPORTED DEVICE ISSUES, LEAKAGE PROBLEMS REMAINS UNKNOWN. THE MANUFACTURER'S ANALYSIS OF THE RETURNED PARTIAL DEVICE KIT DOCUMENTS THE (B)(4) KIT/COMPONENTS WERE SUBJECTED TO A COMBINATION OF INCORRECT USAGE/TECHNIQUE AND EXTREME FORCE. THE MANUFACTURER'S PRODUCT SERVICE REPRESENTATIVES HAS MET WITH THE AFFECTED FACILITY STAFF TO REVIEW THESE PRODUCT EXPERIENCES AND TO REVIEW THE DEVICE KIT'S PERFORMANCE FEATURES, ATTRIBUTES AND COMPONENT FUNCTIONALITY.

    Description of Event or Problem · 1

    (B)(4) RECEIVED REPORTING A 6/14 LEAKAGE INCIDENT DURING USE OF ONE (1) (B)(4) TRANPAC IV MONITORING KIT. THE REPORT STATES "DURING PATIENT'S BATH AFTER SURGERY, A SMALL BLOOD LEAK WAS NOTED ON THE PATIENT'S SHEETS. AFTER TRACING THE SOURCE, IT WAS DETERMINED THAT THERE WAS A PINHOLE LEAK IN PART OF THE ARTERIAL LINE TUBING. PATIENT WAS ASSESSED, VITAL SIGNS REMAINED STABLE AFTER THE INCIDENT WITH NO INJURY NOTED. THIS IS THE THIRD TIME AN INCIDENT HAS OCCURRED THAT INVOLVED A LEAK AT THE CONNECTION OF THE ARTERIAL LINE TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC IV MONITORING KIT MONITORING KIT FPA ICU MEDICAL, INC. 42645-06 2233653

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR