BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2991102 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05370
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 14, 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). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS REPORT OF PERITONITIS CAUSED BY USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. THE ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. THE HP WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED. THE HP WAS TREATED WITH INJECTION VANCOMYCIN (1 G, STAT DOSE), INJECTION REFLIN (1 GM, ONCE DAILY (OD)), INJECTION ECOMER (1 G, OD), INJECTION AMITAX (100 MG, OD), AND INJECTION HEPARIN (500 INTERNATIONAL UNITS (IU), IN ALL BAGS) FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED IF THE HP WAS RE-TRAINED ON PROPER ASEPTIC PROCEDURE. PD THERAPY WAS ONGOING. THE OUTCOME OF THIS PERITONITIS EVENT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95043 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R DIANEAL PD2 2.5% ULTRABAG