BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4852998 · Received June 18, 2015

    Report

    Report Number
    1416980-2015-25695
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 31, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS BORN IN (B)(6). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC (DOSE, ROUTE, AND FREQUENCY NOT REPORTED) FOR THE EVENT. IT WAS UNKNOWN IF THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. AT THE TIME OF THIS REPORT, ANTIBIOTIC TREATMENT AND DIANEAL THERAPY WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397926 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention EXTRNEAL, HOMECHOICE| DIANEAL PD4 AMBUFLEX, DIANEAL PD2 ULTRABAG