BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4141254 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34476
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    June 24, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AS ONSET OF THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFACIDAL AND FORTUM INTRAPERITONEALLY FOR 4 DAYS, AND ORBENINE ORALLY (DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT. NINE DAYS AFTER HOSPITALIZATION, THE PATIENT WAS DISCHARGED AND WAS REPORTED TO BE RECOVERED FROM THE PERITONITIS EVENT. ONE DAY AFTER DISCHARGE, THE PATIENT WAS TREATED WITH VANCOMYCIN (1 GRAM INTRAPERITONEALLY, FREQUENCY NOT REPORTED). VANCOMYCIN DOSE WAS REPEATED THREE DAYS AFTER THE ONSET OF VANCOMYCIN THERAPY. IT WAS REPORTED THAT TWENTY SEVEN DAYS AFTER DISCHARGE, THE PATIENT WAS HOSPITALIZED FOR CLOUDY EFFLUENT. THE CAUSE OF THE CLOUDY EFFLUENT WAS UNKNOWN. THE PATIENT WAS DIAGNOSED WITH ASEPTIC PERITONITIS. THE PATIENT WAS TREATED WITH CEFACIDAL AND FORTUM (DOSES, FREQUENCIES AND ROUTES NOT REPORTED) FOR THE STERILE PERITONITIS. NINETEEN DAYS AFTER THE ONSET OF THE STERILE PERITONITIS, THE PATIENT WAS DIAGNOSED WITH RECURRENT STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND INFLAMMATORY SYNDROME. THE PATIENT WAS NOT HOSPITALIZED FOR THE RECURRENT EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RECOVERED FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. PHYSIONEAL THERAPY WAS ONGOING. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619786 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R 1.36% PHYSIONEAL 35, MINICAP| HOMECHOICE, CASSETTE, TRANSFER SET