BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3001733 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-05979
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 16, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS EVENT WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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 ROOT CAUSE OF THE REPORTED EVENT WAS USE ERROR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND HOSPITALIZED. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS; THE TREATMENT RECEIVED DURING HOSPITALIZATION WAS AN UNKNOWN ANTIBIOTIC AND THE PATIENT IS REPORTED TO BE RECOVERING. THE PATIENT'S PD THERAPY WAS ONGOING THROUGHOUT THE PERITONITIS EPISODE. THE PATIENT'S FOLLOW-UP TREATMENT INCLUDED VANCOMYCIN INTRAPERITONEALLY (IP) EVERY 4 DAYS (DOSE, FREQUENCY NOT REPORTED). THE PERITONITIS WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE SECONDARY TO THE PATIENT'S POOR VISION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104670 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R LOCAL (PD4) AMBUFLEX