BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3855220 · Received June 9, 2014

    Report

    Report Number
    1416980-2014-18332
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 13, 2014
    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 IS A REPORT OF A USE ERROR THAT RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH RESULTED IN PERITONITIS. THE PERITONITIS WAS MANIFESTED AS ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED THE SAME DAY AS ONSET. THE PATIENT WAS TREATED WITH VANCOMYCIN (ROUTE, DOSAGE AND FREQUENCY UNKNOWN) FOR THE PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FIVE DAYS AFTER ADMISSION. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE PERITONITIS. PD THERAPY WAS ONGOING. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334769 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R DIANEAL LOW CALCIUM