BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 1661573 · Received April 8, 2010

    Report

    Report Number
    3005011024-2010-00001
    Event Type
    Other
    Date Received
    April 8, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 11, 2009
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    DTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CODAN, THE MANUFACTURER OF THE VENTED ADMINISTRATION LINE, 72" LARGE BORE, INCLUDED IN THE JACKSON MANIFOLD KIT, WAS MADE AWARE AND ASKED TO CONDUCT AN INVESTIGATION OF THE REPORTED COMPLAINT AND PROVIDED CORRECTIVE AND PREVENTIVE ACTION TAKEN. THE ADMINISTRATION LINE WAS HELD AT THE USER FACILITY AND NOT AVAILABLE FOR THE MANUFACTURER TO INSPECT AS PART OF THE DEVICE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DEFICIENCIES WERE FOUND WHICH COULD HAVE CAUSED THE EVENT AS DESCRIBED. RECORDS FROM CORRECTIVE AND PREVENTIVE ACTION MEETINGS AND IN-HOUSE NON-CONFORMITIES WERE EXAMINED, BUT NO RELATED ISSUES WERE SEEN. IN ADDITION, PRODUCT COMPLAINT FILES WERE REVIEWED FOR ANY SIMILAR OCCURRENCES REGARDING THIS LINE, AND NO OTHER INSTANCES OF REPORTED PIN-HOLES IN THE LINE WERE FOUND. THE MANUFACTURER OF THE VENTED ADMINISTRATION LINE HAS DETERMINED THIS INCIDENT TO BE AN ISOLATED EVENT. WITHOUT THE INCIDENT DEVICE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING AN ANGIOGRAM, AIR BUBBLES WERE INJECTED INTO THE RIGHT CORONARY ARTERY OF THE PATIENT. INTRODUCTION OF THESE BUBBLES CAUSED THE PATIENT'S BLOOD PRESSURE AND HEART RATE TO DROP LESS THAN OPTIMUM LEVELS. ATROPINE WAS GIVEN TO INCREASE THE HEART RATE AND EXTRA FLUIDS WERE DELIVERED TO INCREASE FLUID VOLUME AND BLOOD PRESSURE. THE PATIENT'S VITALS RETURNED TO NORMAL WITHIN A FEW MINUTES. THE PATIENT WAS OBSERVED FOR FURTHER ADVERSE AFFECTS AND WAS DISCHARGED OVERNIGHT TO THE OBSERVATION UNIT. ALL CONNECTIONS IN THE CONTRAST DELIVERY TRAIL WERE INSPECTED FOR TIGHTNESS AND / OR BREAKS. DURING THE INSPECTION, RETROGRADE PRESSURE WAS APPLIED TO THE TUBING AND A PINHOLE WAS DETECTED APPROXIMATELY ONE INCH ABOVE THE CONTRAST MANIFOLD CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL MANIFOLD KIT DTL DEROYAL INDUSTRIES, INC. NA 20053556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention