BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPS VASCULAR POSITIONING SYSTEM - REFURB

    MDR report key: 8789388 · Received July 15, 2019

    Report

    Report Number
    3003898360-2019-00782
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 17, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    OBJ
    PMA / PMN Number
    K123813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE REPORT THE VPS SYMBOL WAS INCORRECT WAS NOT CONFIRMED SINCE THE SAMPLE OR PATIENT CASE DATA WAS NOT RETURNED FOR REVIEW. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE PROBABLE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED, WITHOUT PATIENT CASE DATA TO ANALYZE, AND WITHOUT A SAMPLE. NO FURTHER ACTION WILL BE TAKEN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    VASCULAR ACCESS NURSE USED VPS TO PLACE A PICC ON THE RIGHT SIDE. THERE WAS NO BULLSEYE; HOWEVER , THERE WERE GREEN ARROWS. WITHIN TWO DAYS, THE PATIENT COMPLAINED OF PAIN TO THE ARM. THERE WAS AN ULTRASOUND AND DOPPLER DONE ON THE ARM AND A DVT WAS FOUND IN THE BRACHIAL VEIN, BUT THE PICC WAS FOUND IN THE BRACHIAL ARTERY. THERE WAS NO ABG DONE. THE LINE WAS PULLED RIGHT AWAY, BUT THERE WAS STILL NO PULSATING BLOOD. AFTER FURTHER REVIEW OF THE CHEST X-RAY (WHICH INITIALLY READ AS BEING IN THE SVC) THEY FOUND THE PICC WAS OVER THE CLAVICLE (IT FOLLOWED THROUGH THE SUBCLAVIAN ARTERY) AND THEM COMES DOWN AND TOWARDS THE LEFT APPEARING TO BE IN THE AORTA.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CUSTOMER INFORMATION (6/26/2019): THE PICC WAS PLACED AND THE VPS GAVE A GREEN ARROW PER THE RN THAT PLACED THE LINE (B)(6) 2019. THE RN PLACING THE LINE ORDERED A CHEST X-RAY THAT WAS READ THAT THE LINE WAS IN THE SVC/CAJ. THE RN IN ICU NOTED A LARGE HEMATOMA TO THE INSERTION SITE ONE HOUR AFTER THE LINE WAS PLACED ON (B)(6) 2019. THE PATIENT WAS RESUSCITATED IN THE ICU AND TRANSFERRED TO A MED/SURG FLOOR ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT COMPLAINED OF PAIN AND SWELLING TO THIS EXTREMITY AND WAS SENT FOR A DOPPLER OF THE VESSELS WHERE IT WAS FOUND TO BE A THROMBUS TO THE BRACHIAL VEIN AND THE CATHETER IN THE ARTERY. OTHER REMARKS: THE LINE WAS THEN PULLED BY THE RN THAT PLACED THE LINE AND STATES THAT THERE WAS NO PULSATING BLOOD UPON INITIATION NOR AT THE TIME OF REMOVAL. THE CT/ANGIO THAT WAS PREFORMED SHORTLY AFTER THE PLACEMENT OF THIS LINE ON (B)(6) 2019 WAS THEN RE-EVALUATED ON (B)(6) 2019 AND PER THE MDS NOTE LINE WAS IN THE ARTERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019 WITH ANTICOAGULATION AND IMPROVEMENT OF PAIN, DISCOMFORT, AND REGAINED STRENGTH OF THIS EXTREMITY. IT IS UNKNOWN AT THIS TIME IF THE PATIENT HAS FOLLOWED UP WITH ANY OF THE MD'S OR IF THERE ARE ANY FURTHER RESIDUAL EFFECTS.

    Description of Event or Problem · 1

    VASCULAR ACCESS NURSE USED VPS TO PLACE A PICC ON THE RIGHT SIDE. THERE WAS NO BULLSEYE; HOWEVER , THERE WERE GREEN ARROWS. WITHIN TWO DAYS, THE PATIENT COMPLAINED OF PAIN TO THE ARM. THERE WAS AN ULTRASOUND AND DOPPLER DONE ON THE ARM AND A DVT WAS FOUND IN THE BRACHIAL VEIN, BUT THE PICC WAS FOUND IN THE BRACHIAL ARTERY. THERE WAS NO ABG DONE. THE LINE WAS PULLED RIGHT AWAY, BUT THERE WAS STILL NO PULSATING BLOOD. AFTER FURTHER REVIEW OF THE CHEST X-RAY (WHICH INITIALLY READ AS BEING IN THE SVC) THEY FOUND THE PICC WAS OVER THE CLAVICLE (IT FOLLOWED THROUGH THE SUBCLAVIAN ARTERY) AND THEM COMES DOWN AND TOWARDS THE LEFT APPEARING TO BE IN THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583782 VPS VASCULAR POSITIONING SYSTEM - REFURB CATHETER, ULTRASOUND, INTRAVAS OBJ ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other