BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4123818 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33552
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INITIAL REPORTER PHONE NUMBER - (B)(6). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER CASSETTE. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY MANIFESTED BY NAUSEA, DIARRHEA, AND NO APPETITE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CEFAZOLIN (ONGOING FOR 21 DAYS; DOSE, ROUTE, AND FREQUENCY NOT REPORTED) AND AN UNKNOWN ANTIBIOTIC (DISCONTINUED ON AN UNKNOWN DATE; DOSE, ROUTE, AND FREQUENCY NOT REPORTED) FOR PERITONITIS. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE PATIENT REPORTED THAT THE CAUSE WAS DUE TO SKIN; HOWEVER, THE EXACT CAUSE REMAINS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602463 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention TRANSFER SET, MINI CAP, TITANIUM ADAPTER,| EXTRANEAL.| HOME CHOICE, DIANEAL 1.5%, DIANEAL 2.5%,