BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4103256 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32427
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTIONS OF FORTUM (1 GRAM, FREQUENCY AND ROUTE NOT REPORTED) AND INJECTIONS OF REFLIN (1 GRAM, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581717 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention MINICAP, TITANIUM ADAPTER,| DIANEAL PD2 1.5% AND 2.5% ULTRABAG