BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3222820 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18125
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS BREAK IN ASEPTIC TECHNIQUE. 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, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED FOR A WEEK FOR THE PERITONITIS EVENT. TREATMENT FOR PERITONITIS INCLUDED FORTAZ INTRAPERITONEALLY (IP) (DOSAGE AND FREQUENCY NOT REPORTED). ONE WEEK AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT AGAIN EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND WAS READMITTED TO THE HOSPITAL. IT WAS UNKNOWN IF THE PERITONITIS WAS A REOCCURRENCE OR A RELAPSE OF THE PREVIOUS EPISODE. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET BEEN RETRAINED ON PROPER ASEPTIC TECHNIQUE BECAUSE THE PATIENT REMAINED HOSPITALIZED. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322378 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R DIANEAL 2.5% PD4 AMBUFLEX AND ULTRABAG