BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3142550 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14076
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONSET OF PERITONITIS WAS REPORTED AS (B)(6) 2013. 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 FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HOME PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS THERAPY (PD) USING UNKNOWN BAXTER DISPOSABLES WHICH CAUSED PERITONITIS MANIFESTED BY CLOUDY PERITONEAL EFFLUENT AND ABDOMINAL PAIN. THE ONSET OF PERITONITIS OCCURRED AFTER THE PATIENT HAD WITHDRAWN FROM PD THERAPY AND WAS SWITCHED TO HEMODIALYSIS THERAPY THREE TIMES A WEEK. THE PATIENT WAS HOSPITALIZED FOR 2 WEEKS FOR PERITONITIS. THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAMS INTRAPERITONEALLY (IP) EVERY 5 DAYS AND GENTAMYCIN 60MG IP (FREQUENCY NOT REPORTED). FOLLOWING DISCHARGE FROM THE HOSPITAL, THE PATIENT WAS PLACED ON UNSPECIFIED ORAL ANTIBIOTICS. THE PATIENT RECOVERED FROM PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245180 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL AND EXTRANEAL