BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4812142 · Received June 2, 2015

    Report

    Report Number
    1416980-2015-23662
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 11, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, DIARRHEA, AND CLOUDY EFFLUENT FOR TWO DAYS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. HOSPITALIZATION WAS NOT REPORTED. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC FOR TWO WEEKS (DRUG NAME, DOSE, ROUTE, AND FREQUENCY NOT REPORTED) FOR PERITONITIS. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. RECOVERY STATUS OF THE PATIENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356622 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 1.5% PD4