BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC

    MDR report key: 10828617 · Received November 12, 2020

    Report

    Report Number
    10828617
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 3, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED WITH ACUTE SADDLE PULMONARY EMBOLISM (PE). BILATERAL EKOS CATHETERS WERE PLACED IN CATH LAB. EKOSONIC DEVICE X2 WAS SET UP BY CATH LAB STAFF & BOSTON SCIENTIFIC REP. THE PATIENT WAS ADMITTED TO ICU WITH THE EKOSONIC THERAPY IN PROGRESS. NO ISSUES WERE NOTED OVER THE FOLLOWING HOURS. ICU STAFF REPORT NO ONE OPERATED THE DEVICE AND NO ALARMS WERE HEARD. AT CHANGE OF SHIFT, THE RN NOTED THE TIMER ON ONE OF THE DEVICES WAS OFF. THE CATH LAB & BOSTON SCIENTIFIC REP WAS ENGAGED. THE TIMER WAS RE-STARTED. AT THE END OF THERAPY, THE BOSTON SCIENTIFIC REP DOWN-LOADED THE EVENT LOG WHICH SHOWED AT 2.7 HOURS INTO THE THERAPY, THE CONTROL UNIT POWER CYCLED. THE THERAPY TIME WAS RESET TO '0' AT THIS POINT. AFTER THE CONTROL UNIT POWERED BACK ON, THE 'START' BUTTON WAS NOT PRESSED AND THE THERAPY DID NOT RESUME UNTIL HOURS LATER WHEN THE ISSUE WAS RECOGNIZED. STAFF REPORTED NO ALARMS WERE HEARD THAT WOULD HAVE PROMPTED INVESTIGATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297821 EKOSONIC CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION PT-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA Life Threatening