BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3080357 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10488
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 9, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PD. ON AN UNREPORTED DATE, THE PT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS PATIENT MADE MISTAKE (DETAILS NOT PROVIDED). SUBSEQUENTLY THE PT EXPERIENCED PERITONITIS. SIX DAYS LATER, THE PT WAS TREATED WITH VANCOMYCIN (1.5GM/LIT) AND FORTUM (1.5G/2 LIT) (ROUTES, FREQUENCIES AND LOTS NOT REPORTED). CONCOMITANT THERAPY WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182077 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DIANEAL PD2 2.5% ULTRABAG