BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3051440 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08993
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER CAREGIVERS

    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 PERITONEAL INFECTION IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT HAD A PERITONEAL INFECTION. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFAZOLIN FOR 2 WEEKS FOR PERITONEAL INFECTION AND STOPPED THE TREATMENT. A WEEK LATER, THE PATIENT RESTARTED TREATMENT WITH CEFAZOLIN FOR SEVERAL DAYS. ON AN UNREPORTED DATE, CEFAZOLIN WAS STOPPED AGAIN AND THE PATIENT WAS TREATED WITH VANCOMYCIN (1500 MCG, EVERY 5 DAYS) FOR 3 WEEKS. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153578 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL 1.5%