BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR LE INJECTOR SYSTEM

    MDR report key: 12274103 · Received August 4, 2021

    Report

    Report Number
    1518293-2021-00018
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 7, 2021
    Report Date
    July 8, 2021
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K984088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REGIONAL GUERBET SERVICE RECEIVED A CALL FROM A CUSTOMER WHO SAID THEY WERE SCANNING A PATIENT WHEN THE OPTISTAR LE INJECTOR SELF-ACTIVATED AND INJECTED CONTRAST PART WAY THROUGH A SCAN. CUSTOMER ALSO REPORTED THAT IT WAS CONFIRMED BY A NUMBER OF RADIOGRAPHERS PRESENT THAT NOBODY TOUCHED THE START BUTTON ON THE CONSOLE. THE PATIENT PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT HOME. GUERBET SERVICE WENT ON SITE TO INSPECT THE INJECTOR, TESTED THE POWERHEAD PUSH BUTTONS AND FOUND NO PROBLEM. SERVICE ALSO CLEANED CONTRAST FROM THE TOUCHSCREEN AND RAN TEN TEST RUNS AND THE INJECTOR PERFORMED NORMALLY. SERVICE NOTED THAT THERE WAS NO REMOTE HAND SWITCH ON SITE. SERVICE WENT ON SITE THE FOLLOWING DAY AND COMPLETED A CONSOLE CALIBRATION AND REPORTED THE INJECTOR WAS IN USE AND ENCOUNTERED NO ISSUES. SERVICE CHECKED THE FAULT LOG AND CONFIRMED NO ERRORS WERE LOGGED ON THE DAY THE ISSUE OCCURRED. A NEW POWERHEAD KEYPAD PN 802315 WAS INSTALLED AS A PREVENTIVE MEASURE. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. THE INJECTOR WAS MANUFACTURED IN APRIL 2008, THE SAME TIME A CAPA WAS OPENED FOR UNCOMMANDED MOVEMENT AFTER A DRIP INJECTION. A HARDWARE FIX TO THE MOTOR CONTROL WAS IMPLEMENTED IN JULY 2009 ON THE DRIVER PCB, 802203-1 REV E TO SOLVE THE CAPA, BUT THE INJECTOR SYSTEM IN QUESTION WAS MANUFACTURED PRIOR TO THIS CORRECTIVE ACTION. FURTHER INVESTIGATION INTO THE SPECIFIC 802203-1 BOARD REVISION IS NEEDED AT THIS TIME FOR ADDITIONAL ACTIONS ON THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2021. THE CUSTOMER REPORTED THAT THEY WERE SCANNING A PATIENT THE PREVIOUS EVENING WHEN THE OPTISTAR LE INJECTOR SELF-ACTIVATED AND INJECTED CONTRAST HALF WAY THROUGH A SCAN. IT WAS CONFIRMED BY A NUMBER OF RADIOGRAPHERS PRESENT THAT NOBODY TOUCHED THE START BUTTON ON THE CONSOLE. THE CUSTOMER STATES THAT THE PATIENT WAS ATTACHED AND THAT THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175144 OPTISTAR LE INJECTOR SYSTEM OPTISTAR LE INJECTOR SYSTEM DXT LIEBEL-FLARSHEIM 802001 CI0408D026

    Patients

    Seq Age Sex Outcome Treatment
    1