BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3103219 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11865
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    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 PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPIES WERE NOT REPORTED. THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS SAID TO BE THE HOSPITAL ENVIRONMENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION (INJ) VANCOMYCIN (1GM/4TH DAY, IP), INJ TOBRANEG (20MG EACH BAG) AND CEFAZOLIN (250MG EACH BAG). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202630 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R DIANEAL PD2 1.5%, DIANEAL PD2 2.5%