BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE

    MDR report key: 6571558 · Received May 17, 2017

    Report

    Report Number
    9612452-2017-00025
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    March 21, 2017
    Report Date
    May 15, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REFERENCE (B)(4) IS NOT CLEARED FOR SALES IN THE USA, BUT ITS CATHETER IS SIMILAR TO THE PRODUCT REFERENCE (B)(4) CLEARED UNDER #510 K130576. BATCH HISTORY REVIEW: THE MANUFACTURING FILE WAS REVIEWED. IT IS COMPLIANT WITH OUR SPECIFICATIONS AND NO ABNORMALITY WAS DETECTED. NO OTHER SIMILAR COMPLAINT WAS REPORTED ON THIS BATCH OF ACCESS PORTS. INVESTIGATION: DESPITE SEVERAL REQUESTS, THE INVOLVED DEVICE WAS NOT RETURNED FOR ANALYSIS. THE X-RAY PICTURES RECEIVED SHOW : ON (B)(6) 2017, A CATHETER PLACED VIA RIGHT JUGULAR VEIN. BUT IT IS NOT POSSIBLE TO SEE IF THE CATHETER IS CORRECTLY CONNECTED. ON (B)(6) 2017, THE DISCONNECTION AND MIGRATION OF THE CATHETER. CONCLUSION: WITHOUT THE DEVICE FOR EVALUATION, NO CONCLUSION CAN BE DRAWN CONCERNING THE EXACT ROOT CAUSE OF THE CATHETER DISCONNECTION. HOWEVER IT IS WORTH NOTING THAT CATHETER DISCONNECTION IS A KNOWN RISK OF ACCESS PORT IMPLANTATION AND, IN THIS CASE, IT HAPPENED ONLY 1 WEEK AFTER THE IMPLANTATION. THIS LEADS US TO HYPOTHESISE THAT THE CATHETER WAS NOT CORRECTLY CONNECTED TO THE DEVICE BY THE USER AND THE REPETITIVE MOVEMENTS OF THE PATIENT LED TO THIS PREMATURE DISCONNECTION. THE IFU'S SPECIFY HOW TO CONNECT THE CATHETER TO THE ACCESS PORT AND THE RISKS OF INCORRECT CONNECTION. B BRAUN (B)(4) HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE TO US. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION OR THE DEVICE, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Description of Event or Problem · 1

    "ON (B)(6) 2017 THE PATIENT WAS IMPLANTED WITH THE INFUSION PORT (IMPLANTABLE VASCULAR ACCESS SYSTEM) FOR CHEMOTHERAPY. CHEMOTHERAPY WAS NOT STARTED YET. ON (B)(6) 2017, DURING ROUTINE FLUSH OF INFUSION PORT, LEAKAGE WAS DISCOVERED. X-RAY IMAGING WAS PERFORMED. IT WAS FOUND THAT PART OF THE CATHETER HAD FALLEN OFF AND MIGRATED TO HEART. INTERVENTIONAL OPERATION WAS PERFORMED AND THE PART OF CATHETER WAS TAKEN OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353334 CELSITE ACCESS PORT SYSTEM LJT B .BRAUN MEDICAL SAS 4430095 36914415

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention