BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3914492 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21609
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT (PREVIOUSLY REPORTED AS RECOVERING). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT DID NOT WEAR A MASK AND DID NOT CLEAN THE AREA BEFORE STARTING PD THERAPY. THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY FOR THE EVENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) FORTUM (1G, FREQUENCY NOT REPORTED) AND IP VANCOMYCIN (1G, FREQUENCY NOT REPORTED) FOR PERITONITIS. DIANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390274 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| R DIANEAL 2.5% ULTRABAG THERAPY| DIANEAL 1.5% ULTRABAG THERAPY