BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4140913 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34432
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    May 26, 2014
    Report Date
    July 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE MANIFESTATION OF PERITONITIS WAS UNKNOWN. THE CAUSE OF THE PERITONITIS IS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR TWO DAYS FOR THE EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN AND CEFTAZIDIME FOR PERITONITIS (ROUTE, DOSE, AND FREQUENCY UNKNOWN) FOR 14 DAYS. THE PATIENT RECOVERED FROM THE PERITONITIS FIFTEEN DAYS AFTER THE ONSET AND WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, PERITONEAL DIALYSIS THERAPY WAS ONGOING. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617934 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R TITANIUM ADAPTER, MINICAP, TRANSFER SET| HOMECHOICE, DIANEAL AMBUFLEX 1.5%, 2.5%, EXTRANEAL