BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2974234 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04461
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE BY PATIENT DESCRIBED AS TOUCH CONTAMINATION. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. . PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. 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. 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 HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED). ON AN UNREPORTED DATE, TWO DAYS PRIOR TO EXPERIENCING THE SYMPTOMS OF PERITONITIS, THE PATIENT EXPERIENCED STOMACH FLU. TEN DAYS PRIOR TO THIS REPORT, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY FLUID. THE PATIENT ALSO EXPERIENCED ABDOMINAL TENDERNESS (ONSET DATE NOT REPORTED). THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS USING ULTRABAG THERAPY (DOSE, FREQUENCY, NOT REPORTED). THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENTS. ON AN UNSPECIFIED DATE, THE PATIENT WAS RE-TRAINED IN PROPER ASEPTIC TECHNIQUE FOR PD THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND PD THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77703 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DIANEAL 2.5% LOW CALCIUM AMBUFLEX