BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3250803 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19945
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS A TOUCH CONTAMINATION FROM THE PATIENT'S PET DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED BACTERIAL PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH FORTAZ INTRAPERITONEALLY (IP) (DOSAGE AND FREQUENCY UNKNOWN). THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. THE PATIENT RECOVERED FROM PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353474 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention DIANEAL 2.5%, HOMECHOICE, MINICAP, DRAIN BAG| HOMECHOICE AUTOMATED PD SET WITH CASSETTE,| MINICAP TRANSFER SET, TITANIUM ADAPTER