BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJ. OPTIV DH,SI W/OEM

    MDR report key: 5500761 · Received March 15, 2016

    Report

    Report Number
    1518293-2016-00016
    Event Type
    Injury
    Date Received
    March 15, 2016
    Date of Event
    February 18, 2016
    Report Date
    February 18, 2016
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN AIR INJECTION OCCURRED DURING A PROCEDURE. A REGIONAL SERVICE ENGINEER REMOVED THE INJECTOR FROM THE CUSTOMER SITE AND TOOK IT THEIR SERVICE CENTER AND FOUND THE INJECTOR TO BE WITHIN MANUFACTURERS SPECIFICATIONS. THERE WERE NO PROBLEMS OR MALFUNCTIONS DETECTED THAT WOULD CAUSE A PROBLEM WITH THIS INJECTOR. AIR INJECTIONS ARE TYPICALLY NOT CAUSED BY AN INJECTOR MALFUNCTION. THE INJECTOR WAS CYCLED MANY TIMES AND ALWAYS FILLED THE SYRINGES CORRECTLY, AND AFTER FILLING THE INJECTOR INDICATED TO CHECK THAT THERE WERE NO BUBBLES IN THE SYRINGES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS ONE PATIENT (MALE) WAS INJECTED WITH APPROXIMATELY 80 CM3 OF AIR IN VENTRICLE. ADDITIONALLY USED WERE A PREFILLED SYRINGE OPTIRAY ULTRAJECT 320 MG/ML, 125 ML AND SALINE SOLUTION LOADED IN A EMPTY SYRINGE REF. 800096, LOT C022097U. THE PERSON WHO ATTENDED THE PATIENT DURING INJECTION DID NOT KNOW HOW THIS AIR WAS INJECTED. THE PHYSICIAN CARING FOR THE PATIENT CONFIRMED: THE PATIENT FELT BAD AFTER THE EXAMINATION, WITH PAIN ON THORAX AND DYSPNEA, DUE TO IT, THE AIR IN VENTRICLE WAS DISCOVER IN THE SCAN. ELECTROCARDIOGRAM WAS NORMAL, THE PATIENT WAS UNDER OBSERVATION FOR 2-3 HOURS, THE PAIN AND DYSPNEA DISAPPEARED. HE WAS UNDER OBSERVATION FOR 1/2 DAY JUST AS PRECAUTION. NO OTHER CONSEQUENCES TO THE PATIENT. THE PATIENT WAS RECOVER WITHOUT ANY IMPACT ON HIS HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157609 INJ. OPTIV DH,SI W/OEM INJ. OPTIV DH,SI W/OEM IZQ LIEBEL FLARSHEIM INJ. OPTIV DH,SI W/OEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other