BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASONOVA VPS G4 CONSOLE/ACCESSORIES

    MDR report key: 18693656 · Received February 13, 2024

    Report

    Report Number
    3003898360-2024-00218
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 19, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). VPS G4 SYSTEM S/N: (B)(6) WITH ACCESSORIES WAS RETURNED. A VISUAL EXAMINATION REVEALED ALL RETURNED ITEMS WERE IN ACCEPTABLE CONDITION WITH NO OBVIOUS EXTERNAL DEFECTS OR ANOMALIES OBSERVED. DURING FUNCTIONAL TESTING OF THE RETURNED CONSOLE , NO PROBLEM WAS OBSERVED WITH THE OPERATION OF THE CONSOLE. THE COMPLAINT IS RELATED TO POSITIONING OF THE CATHETER, WHICH IS NOT SOMETHING THAT CAN BE REPLICATED IN SERVICE. A DEVICE HISTORY RECORD REVIEW PERFORMED ON THE CONSOLE DID NOT REVEAL ANY MANUFACTURING OR SERVICING RELATED ISSUES. THE REPORTED ISSUE CANNOT BE CONFIRMED AT THIS TIME. A PROBABLE CAUSE OF THIS EVENT CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: PLACEMENT FOR ICU CARE. PICC LINE PLACED WITH NO COMPLICATIONS. SUSTAINED BLUE BULLS EYE NOTED ON VPS MACHINE WITH ARM BEING DROPPED TO SIDE OF BODY. DURING PRE-ASSESSMENT FOR LINE PLACEMENT, INSERTING VAT RN DID VERBALIZE ISSUES WITH EXTERNAL MEASUREMENTS DUE TO PATIENT HAVING C-COLLAR. PROCEDURE WAS FINISHED AND LINE WAS CLOSED WITH NO NOTICEABLE COMPLICATIONS. AS PER VAT RN VITAL SIGNS ON MONITOR AND PATIENT GCS WERE NOTED TO HAVE NO CHANGES THROUGHOUT PROCEDURE. X-RAY FROM 1/11/24 AT 06:24, REPORTED THE PICC LINE IN THE RIGHT ATRIUM. X-RAY FROM 1/12/24 AT 04:35, REPORTED THE PICC LINE IN THE RIGHT ATRIUM ALSO. VASCULAR TEAM WAS CONTACTED ON 1/12/24 IN THE MORNING. THE TEAM REACHED OUT TO ME AT 08:58, TO NOTIFY ME THAT THE PICC LOOKED DEEP ON X-RAY THAT RECOMMENDATIONS WERE MADE TO RESHOOT AN X-RAY DUE TO PATIENT BEING IN A CROOKED POSITION IN MORNING X-RAY. PATIENT REPOSITIONED. X-RAY RE-SHOT AT 09:53, REPORTED THE PICC LINE TIP LOCATION WAS IN THE MID R ATRIUM. THE PATIENT WAS REPORTED AS FINE POST THE CORRECTION, THERE WAS NO MORE CONSEQUENCES OR HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: PLACEMENT FOR ICU CARE. PICC LINE PLACED WITH NO COMPLICATIONS. SUSTAINED BLUE BULLS EYE NOTED ON VPS MACHINE WITH ARM BEING DROPPED TO SIDE OF BODY. DURING PRE-ASSESSMENT FOR LINE PLACEMENT, INSERTING VAT RN DID VERBALIZE ISSUES WITH EXTERNAL MEASUREMENTS DUE TO PATIENT HAVING C-COLLAR. PROCEDURE WAS FINISHED AND LINE WAS CLOSED WITH NO NOTICEABLE COMPLICATIONS. AS PER VAT RN VITAL SIGNS ON MONITOR AND PATIENT GCS WERE NOTED TO HAVE NO CHANGES THROUGHOUT PROCEDURE. X-RAY FROM (B)(6) 2024 AT 06:24, REPORTED THE PICC LINE IN THE RIGHT ATRIUM. X-RAY FROM (B)(6) 2024 AT 04:35, REPORTED THE PICC LINE IN THE RIGHT ATRIUM ALSO. VASCULAR TEAM WAS CONTACTED ON (B)(6) 2024 IN THE MORNING. THE TEAM REACHED OUT TO ME AT 08:58, TO NOTIFY ME THAT THE PICC LOOKED DEEP ON X-RAY THAT RECOMMENDATIONS WERE MADE TO RESHOOT AN X-RAY DUE TO PATIENT BEING IN A CROOKED POSITION IN MORNING X-RAY. PATIENT REPOSITIONED. X-RAY RE-SHOT AT 09:53, REPORTED THE PICC LINE TIP LOCATION WAS IN THE MID R ATRIUM. THE PATIENT WAS REPORTED AS FINE POST THE CORRECTION, THERE WAS NO MORE CONSEQUENCES OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136953 VASONOVA VPS G4 CONSOLE/ACCESSORIES CATHETER ULTRASOUND VASCULAR OBJ TELEFLEX MEDICAL 73K2100440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.