BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3854228 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18223
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY SORE STOMACH, TROUBLE IN BOWELS AND CRAMPING. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN (ON TUESDAY, THURSDAY AND SATURDAY; DOSE AND ROUTE OF ADMINISTRATION WAS NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, VANCOMYCIN WAS STOPPED AND PERITONITIS RECURRED. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. FURTHER TREATMENT WAS NOT REPORTED. FOUR DAYS AFTER THE HOSPITALIZATION, DIANEAL AND EXTRANEAL THERAPIES WERE DISCONTINUED AND THE PATIENT STARTED HEMODIALYSIS. ON THE SAME DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332937 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5% AND EXTRANEAL 7.5%