BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4792245 · Received May 22, 2015

    Report

    Report Number
    1416980-2015-22570
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 30, 2015
    Report Date
    May 1, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE 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. ON THE DAY OF ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. DIANEAL THERAPIES WERE ONGOING. AFTER TEN DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335911 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization DIANEAL 1.5% AND 2.5% LOW CALCIUM SINGLEBAG| DIANEAL 1.5% AND 2.5% LOW CALCIUM ULTRABAG