BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAMIC

    MDR report key: 2890668 · Received November 15, 2012

    Report

    Report Number
    2890668
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 14, 2012
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS (B)(6) OLD GENTLEMAN UNDERWENT EMERGENCY CARDIAC CATH PROCEDURE FOR NON-Q-WAVE MI (MYOCARDIAL INFARCTION). IT IS UNCLEAR AT WHAT POINT THE ARTERIAL LINE WAS INSERTED. POST CATH PROCEDURE, WHEN THE PATIENT RETURNED FROM THE CARDIAC CATH LAB (CCL), HIS ARTERIAL PRESSURE WAS NOTED TO BE WITH A SYSTOLIC READING OF 70S. THE PRESSURE ON THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN THE 60S WITH AN AUGMENTED SYSTOLIC BLOOD PRESSURE (SBP) IN THE 70S. PRIOR TO THE PATIENT LEAVING THE CATH LAB, SBP AND HEART RATE (HR) WERE NOTED TO BE STABLE. THE PATIENT WAS ON VASOPRESSIN, LEVOPHED AND EPINEPHRINE DRIPS. AFTER ASSESSING THE PATIENT, THE MANIFOLD DEVICE, WHICH WAS USED PART OF AN IABP SYSTEM, WAS NOTED TO BE LEAKING AND THE WAS A LARGE WET AREA UNDER THE DEVICE. VASOPRESSIN WAS INFUSING THROUGH THE SYSTEM AT THE TIME THE DEVICE MALFUNCTION WAS DISCOVERED. THE BED LINEN WAS SOAKED. THE DRIPS WERE IMMEDIATELY CHANGED OVER TO THE RIGHT INTERNAL JUGULAR TRIPLE LUMEN CATHETER (RIJ TLC) AND THE PRESSURE STABILIZED TO A SBP IN THE 120S. THE MANIFOLD DEVICE WAS CHANGED TO A NEW DEVICE WITH NO FURTHER INCIDENTS. THE DEVICE IS BEING RETAINED IN THE RISK MANAGEMENT OFFICE OF THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAMIC PRESSURE MONITORING MANIFOLD DRS NAVILYST MEDICAL 70039355 4442525

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR OTHER