BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3180530 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16009
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THERE WAS BREAK IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. FIVE DAYS LATER THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFAZOLIN-500MG (FREQUENCY AND ROUTE NOT REPORTED) FROM DAY 1 TO DAY 7 AND THEN FLUCONAZOLE-500MG (FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. RETRAINING ON PROPER ASEPTIC TECHNIQUE AND PROCEDURE WAS PERFORMED. NO ADDITIONAL INFORMATION INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280215 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CALCIUM CARBONATE (CACO3)| DIANEAL PD2 WITH 1.5% DEXTROSE| FERROUS SULFATE (FESO4)| AMLODIPINE| SODIUM BICARBONATE (NAHCO3)| ERYTHROPOIETIN (EPO)