BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3842293 · Received June 1, 2014

    Report

    Report Number
    1416980-2014-17580
    Event Type
    Injury
    Date Received
    June 1, 2014
    Report Date
    May 7, 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): THE PATIENT WAS REPORTED TO HAVE DEVELOPED PERITONITIS ON AN UNREPORTED DATE IN (B)(6) 2013.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 MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT STOPPED PD THERAPY AND THE PD CATHETER WAS REMOVED. THE PATIENT WAS SWITCHED TO HEMODIALYSIS AND LATER RESUMED PD THERAPY. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE PERITONITIS (DOSE, ROUTE, AND FREQUENCY NOT REPORTED). THE PATIENT RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320640 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DIANEAL 1.5% AND 2.5%, EXTRANEAL 7.5%| MULTIVITAMINS (UNSPECIFIED), VITAMIN D, HOMECHOICE| BABY ASPIRIN, BOWEL MEDICATION (UNSPECIFIED)