BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 2879543 · Received December 14, 2012

    Report

    Report Number
    2025816-2011-00096
    Event Type
    Other
    Date Received
    December 14, 2012
    Date of Event
    March 30, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE INVOLVED 42589-05 TRANSPAC IV MONITORING KIT WAS NOT RETURNED TO THE MFR FOR ANALYSIS AND CONFIRMATION.

    Description of Event or Problem · 1

    (B)(6) REC'D REPORTING A BREAKAGE/LEAKAGE INCIDENT WITH INITIAL USE OF ONE (1) 42589-05 TRANSPAC IV MONITORING KIT. THE (B)(6) DESCRIBES A 03/30 INCIDENT WHERE A "...NEW TRANSDUCER WAS CRACKED AND LEAKED NEAR THE PORT CONNECTING TO CENTRAL LINE DURING FIRST USE. MALFUNCTION SEEN IMMEDIATELY AFTER FLUID STARTED AGAIN AND TRANSDUCER WAS CHANGED. THE PT WAS NOT HARMED". THE DEVICE WAS PRE-TESTED DURING SET-UPS WHERE NO FUNCTIONAL ISSUES WERE DETECTED. THE INVOLVED 42589-05 DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS AND INVESTIGATION. (B)(4). A REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST/LOT # AND SIMILAR PROBLEM RECORDED NO ADDITIONAL REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC IV MONITORING KIT MONITORING DEVICE DRS ICU MEDICAL, INC. 42589-05 2073624

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR