BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4101936 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32225
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). ADDITIONAL INFORMATION: THE DATE OF ONSET WAS REPORTED AS THREE WEEKS FROM THE TIME OF THIS REPORT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A HERNIA COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE HERNIA WAS NOT REPORTED. THE HERNIA WAS DIAGNOSED PRIOR TO PATIENT STARTING THE PD THERAPY. TWO MONTHS PRIOR TO RECEIPT OF THIS REPORT, THE PATIENT HAD A SURGICAL REPAIR DONE FOR HERNIA AND HAD THE PD CATHETER PLACED AT THE SAME TIME. THE PATIENT STATED THAT THREE WEEKS PRIOR TO THIS REPORT, THE HERNIA GOT POPPED AND WAS LEAKING. THE PATIENT WAS SCHEDULED TO HAVE SURGERY FOR HERNIA EIGHTEEN DAYS AFTER THE RECEIPT OF THIS REPORT. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM HERNIA. THE PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582705 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention DIANEAL 1.5% AND 2.5% AMBUFLEX