BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLYBOOK CONSOLE WITH PRINTER

    MDR report key: 3640019 · Received January 3, 2014

    Report

    Report Number
    3006795936-2014-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    December 27, 2013
    Report Date
    December 27, 2013
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K103260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THIS EVENT OCCURRED ON A FEMALE PATIENT WITH THE INSERTION SITE BEING THE RIGHT ARM. WHILE ACCESSING THE PATIENT USING THE FLYBOOK CONSOLE, THE CLINICIAN HAD CONCERN OVER WHICH VESSEL WAS THE ARTERY AND WHICH WAS THE VEIN BECAUSE THEY WERE EXTREMELY CLOSE TOGETHER. SHE STUCK WHAT SHE BELIEVED WAS THE VEIN, HAVING THE CONFIDENCE TO MOVE FORWARD WITH THE PROCEDURE BECAUSE SHE WAS USING VPS. THE CASE, IN HER ESTIMATION, WAS FAIRLY STANDARD AFTER THE INITIAL STICK AND VPS SHOWED A GREEN ARROW UNTIL A BLUE BULLS-EYE WAS OBTAINED. HOWEVER, DURING THE POST-INSERTION CHEST X-RAY PROCESS, THE RADIOLOGISTS COULDN'T CONFIRM WHETHER THE PICC WAS IN THE SVC OR IN AN ARTERY. STILL FEELING UNEASY, BLOOD GASES WERE DRAWN VIA RESPIRATORY THERAPY. THE READINGS WERE CONSISTENT WITH AN ARTERY STICK. THE PICC WAS REMOVED AND REPLACED. THE SECOND PICC WAS CONFIRMED AS ACCURATELY PLACED BY THE RADIOLOGY GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4413 FLYBOOK CONSOLE WITH PRINTER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1