BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3173192 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15574
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 24, 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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY AND THE PT SUBSEQUENTLY EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL 1.5% AMBUFLEX (DOSE, FREQUENCY, AND LOT NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. IT WAS REPORTED THE CAUSE OF THE PERITONITIS WAS POSSIBLY DUE TO THE PT HAVING DIVERTICULITIS AT THE TIME OF THE EVENT OR DUE TO CONTAMINATION. THE PT HAD NOT BEEN WEARING A MASK WHILE PERFORMING PD THERAPY FOR THE PAST YEAR. ON AN UNREPORTED DATE, THE PT WAS RE-TRAINED IN ASEPTIC PROCEDURES FOR PD THERAPY. ON AN UNREPORTED DATE, THE PT RECOVERED FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273418 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL 1.5% AMBUFLEX