BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3250477 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19898
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS THE PATIENT MADE A MISTAKE AND DID NOT WEAR A MASK DURING PERITONEAL DIALYSIS (PD) THERAPY WHILE USING UNKNOWN BAXTER PD DISPOSABLES, WHICH CAUSED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED FOR PERITONITIS WITH VANCOMYCIN AND FORTAM (DOSE, ROUTE AND FREQUENCY NOT REPORTED). AT THE TIME OF THIS REPORT, THE OUTCOME OF PERITONITIS WAS UNKNOWN. THE PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351057 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention EXTRANEAL THERAPY