BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 2411063 · Received December 22, 2011

    Report

    Report Number
    2025816-2011-00056
    Event Type
    Other
    Date Received
    December 22, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UFMW RECEIVED REPORTING A BREAKAGE PROBLEM WITH USE OF ONE (1) 42500-02 TRANPAC IV MONITORING KIT. THE REPORT STATES "DURING ARTERIAL LINE CHANGE, WHEN RN TRIED TO TIGHTEN THE TRANSDUCER, THE STOPCOCKS BROKE OR WERE BROKEN ON THE TRANSPAC IV MONITORING KIT." THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. IT IS UNKNOWN HOW LONG THE DEVICE WAS IN USE WHEN THE PROBLEM OCCURRED. THE INVOLVED DEVICE WAS DISCARDED. MANUFACTURER'S INVESTIGATION: A REVIEW OF THE MFG. LOT NUMBER 2076364 (MFG. DATE 11/2010) SHOWS 501 UNITS WERE MFG. TESTED, INSPECTED AND RELEASED. A THREE (3) YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/SIMILAR ISSUE RECORDED NO ADDITIONAL REPORTS. CONCLUSION: THE EXACT CAUSE(S) OF THE REPORTED PRODUCT EXPERIENCE IS UNKNOWN. THIS REPORT AND THE ASSOCIATED INFORMATION HAVE BEEN ENTERED IN THE MANUFACTURER'S DATABASE FOR ANALYSIS AND TRENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC IV MONITORING KIT MONITORING KIT FPA ICU MEDICAL, INC. 42500-02 2076364

    Patients

    Seq Age Sex Outcome Treatment
    1