BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VPS BEDSIDE KIT

    MDR report key: 3202098 · Received June 27, 2013

    Report

    Report Number
    3006795936-2013-00016
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 26, 2013
    Manufacturer
    VASONOVA
    Product Code
    OBJ
    PMA / PMN Number
    K103255
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BIOSENSOR WAS BEING USED WITH A BARD POWER PICC SOLO CATHETER. THE CATHETER WAS BEING INSERTED INTO A FEMALE PT'S LEFT BRACHIAL VEIN IN THE RADIOLOGY DEPARTMENT. THE PT HAD CHRONIC LOW BLOOD PRESSURE. THE FLUSH TEST WAS PERFORMED AND SHOWED NORMAL DOPPLER FUNCTION. UPON INSERTION, THERE WAS LITTLE DOPPLER SIGNAL AND A YELLOW TRIANGLE SYMBOL APPEARED ON THE CONSOLE. THE PICC LINE WAS INSERTED FURTHER INTO THE PT AND THE DOPPLER FLOW BECAME VISIBLE AND A GREEN ARROW APPEARED ON THE CONSOLE. FROM THAT POINT, THE CLINICIAN SLOWLY ADVANCED AND ELEVATED P-WAVES WERE PRESENT. THE DOPPLER WAS NOT REAL STRONG BUT WAS FUNCTIONAL. THE BLUE BULLSEYE THEN APPEARED ON THE CONSOLE AND THE IMAGE WAS SAVED. UPON TAKING AN X-RAY, THE READING PHYSICIAN CONFIRMED THE PICC WAS NOT IN FACT PLACED IN AN ARTERY AND RESIDING NEAR THE AORTA. AS A RESULT, THE CATHETER WAS THEN REMOVED AND WAS PLACED ON THE OPPOSITE SIDE. THE NURSE HELD PRESSURE ON THE ARTERY SITE AND SWELLING OF THE UPPER ARM WAS PRESENT. THEY WILL CONTINUE TO MONITOR PT FOR ANY ADD'L COMPLICATIONS. THERE WAS A DELAY IN TREATMENT WITH NO PT HARM AND NO PT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293343 VASONOVA VPS BEDSIDE KIT CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA V1303011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BARD POWER PICC SOLO CATHETER