BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPAC IV MONITORING KIT

    MDR report key: 1732081 · Received June 10, 2010

    Report

    Report Number
    2025816-2010-00050
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 9, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED PRODUCT PROBLEM WAS NOT REPLICATED. THE EXACT CAUSE OF THE PROBLEM IS UNK AND CANNOT BE DETERMINED WITH CERTAINTY AT THIS TIME. THE RETURNED 42587-05 MONITORING KIT AND COMPONENTS MEET ALL PERFORMANCE SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    COMPLAINT INITIALLY REC'D REPORTING ERRATIC READINGS WITH ONE (1) 42587-05 TRANSPAC IV MONITORING KIT. THE INITIAL REPORT STATED "AFTER THE PACKAGE WAS OPENED, IT ZEROED FOR AWHILE AND WOULD THEN DRIFT BACK. THE DEVICE WAS REPLACED AND THE PROBLEM WENT AWAY." THERE WERE NO REPORTED ADVERSE PT EVENTS. F/U INFO REC'D FROM A UFMW WHICH STATED "PT WAS TRANSFERRED BACK TO BED. THE ARTERIAL LINE WOULD NOT READ. ATTEMPTED TO ZERO THE LINE, AND RECEIVED READING "SENSOR" OR "PRESSURE." CHANGED ARTERIAL LINE CABLE... SAME READINGS... SWITCHED TUBING AND ARTERIAL LINE STARTED WORKING AGAIN." MFR'S COMPLAINT ANALYSIS: REC'D ONE USED 42587-05 TRANSPAC IV MONITORING KIT. FUNCTIONAL TESTING AND ANALYSIS: THE MONITORING KIT/COMPONENTS WERE TESTED PER THE PRODUCT PERFORMANCE SPECIFICATIONS. THE 42587-05 TRANSPAC IV TRANSDUCER CABLE WAS ELECTRICAL TESTED FOR FAILURE ANALYSIS. THE TRANSDUCER ASSEMBLY WAS ATTACHED TO A MONITOR, ZEROED AND 100MMHG AIR APPLIED. A MANIPULATION TEST WAS PERFORMED AT BOTH SETTINGS (0MMHG AND 100MMHG) ON THE HOUSING AND THE PHONE JACK CONNECTOR ENDS. THE RESULTS RECORDED THE WAVEFORM ON THE MONITOR WAS STABLE DURING BOTH TESTS (TWIST AND PIVOT). THERE WERE NO OUT OF SPECIFICATION CONDITIONS REPLICATED/FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSPAC IV MONITORING KIT MONITORING KIT DRS ICU MEDICAL, INC. 42587-05 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO