BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VPS BEDSIDE KIT

    MDR report key: 3140027 · Received May 29, 2013

    Report

    Report Number
    3006795936-2013-00010
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 28, 2013
    Manufacturer
    VASONOVA
    Product Code
    OBJ
    PMA / PMN Number
    K103255
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RIGHT BASILIC VEIN AT THE BEDSIDE. THE STYLET WAS CALIBRATED AND THE FLUSH TEST WAS DONE. THE CLINICIAN OBTAINED GREAT DOPPLER AND P-WAVES, SO WAS ABLE TO GET A BLUE BULLSEYE. THE CLINICIAN PUT THE PATIENT'S ARM DOWN AND THEN TRIED TO IDENTIFY THE RIGHT ATRIUM. THEY KEPT INSERTING THE PICC AND IT STAYED ON BLUE BULLSEYE AND NEVER CHANGED. SHE EVEN PULLED BACK 5CM AND THE CONSOLE STILL GAVE HER A BLUE BULLSEYE. THE CATHETER WAS PLACED SUCCESSFULLY AND A CHEST X-RAY WAS TAKEN WHICH SHOWED THE CATHETER WAS APPROXIMATELY 1CM INTO THE RIGHT ATRIUM. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED WHEN THE CLINICIAN AND SALES REP WATCHED THE PLAYBACK, THE PLAYBACK ONLY SHOWED A FLICKER OF THE BLUE BULLSEYE AND SHOWED THAT IT ENDED ON A GREEN SYMBOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233887 VASONOVA VPS BEDSIDE KIT CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA V1301050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK