BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3090562 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11151
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF CONSTIPATION AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS CONSTIPATION. ON AN UNREPORTED DATE, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH INJECTION FORTUM1GM (TWO BAGS) AND INJECTION AMIKACIN 125MG (1ST BAG) ROUTE AND FREQUENCY NOT REPORTED. IT WAS NOT REPORTED IF REMEDIAL TREATMENT WAS ONGOING. AS OF THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192123 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R DIANEAL 2.5% ULTRABAG