BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KDJ

    MDR report key: 3059058 · Received April 15, 2013

    Report

    Report Number
    1416980-2013-09378
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS CLARIFIED THAT THIS CASE WAS RECEIVED ONLY FROM A NURSE. THE CONSUMER WAS NOT A REPORTER.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT, COINCIDENT WITH PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT HAD PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS (4 TIMES DAILY) FOR THE PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAD NOT YET RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161384 KDJ KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2L AND 5L 1.5%