BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3232079 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18776
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 A 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 THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS MANIFESTED BY CLOUDY PERITONEAL EFFLUENT. THIS OCCURRED DURING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY WHILE USING UNKNOWN BAXTER DISPOSABLES. PERITONITIS WAS DIAGNOSED WHILE THE PATIENT WAS HOSPITALIZED FOR AN UNREPORTED REASON. IT WAS NOT REPORTED IF THE PERITONITIS PROLONGED THE HOSPITALIZATION STAY. AT THE TIME OF THIS REPORT, ANTIBIOTICS HAD NOT YET BEEN INITIATED AS SOME OF THE LAB RESULTS WERE STILL PENDING. OUTCOME OF PERITONITIS WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332493 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other DIANEAL PD2 1.5% AND 4.25%