BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR POSITIONING SYSTEM - REFURB

    MDR report key: 4894969 · Received July 7, 2015

    Report

    Report Number
    2518433-2015-00005
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 13, 2015
    Report Date
    June 29, 2015
    Manufacturer
    VASONOVA INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EVALUATION OF THE RETURNED DATA CASE. ANALYSIS OF THE CONSOLE AND DATA CASE INDICATED THAT THE UNIT PERFORMED AS INTENDED AND A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. A SENIOR ALGORITHM SCIENTIST REVIEWED THE SAVED PROCEDURE DATASET AND CONCLUDED THAT THE TIP WAS IN THE DESIRED LOCATION AND THEN MOVED TO A LOWER AREA. A POTENTIAL CAUSE IS MOVEMENT OF THE CATHETER DURING THE STYLET REMOVAL PROCEDURE OR THE PATIENT MOVING AFTER THE CATHETER PLACEMENT. OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT BECAUSE THE CATHETER TIP WAS MOVED AFTER THE BLUE BULLSEYE WAS ATTAINED. A CUSTOMER IN-SERVICE HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S BASILIC VEIN IN THE INTENSIVE CARE UNIT WITH THE USE OF VPS. DURING INSERTION, A BLUE BULLSEYE WAS OBTAINED. A CHEST X-RAY WAS TAKEN AND SHOWED THE PICC FLIPPED BACK INTO THE BRACHIOCEPHALIC/SUBCLAVIAN VEIN POST STEADY BLUE BULLSEYE. AS A RESULT, THE CLINICIAN POWER FLUSHED THE PICC TO STRAIGHTEN OUT AND REPOSITIONED INTO THE SVC. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438000 VASCULAR POSITIONING SYSTEM - REFURB CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VASONOVA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1