BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3930798 · Received July 12, 2014

    Report

    Report Number
    1416980-2014-22466
    Event Type
    Injury
    Date Received
    July 12, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. AS A RESULT, THE SERVICE HISTORY REVIEW AND/OR DEVICE HISTORY REVIEW WERE NOT PERFORMED AS PART OF THE INVESTIGATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERITONEAL LEAK COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. A SURGERY WAS SCHEDULED TO REPAIR THE LEAK. THERE WERE NO SYMPTOMS OF OVERFILL REPORTED. THE OUTCOME AND CAUSE OF THE LEAK WERE NOT REPORTED. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408540 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention