BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4231975 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39107
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. 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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER SPECIFIED AS THE PATIENT WAS NON-COMPLIANT WITH PERITONEAL DIALYSIS TREATMENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH INTRAVENOUS MERONEM (500MG, FREQUENCY AND DURATION NOT REPORTED). THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. PERITONEAL DIALYSIS THERAPY WAS LATER DISCONTINUED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715068 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R DIANEAL PD4 ULTRABAG AND EXTRANEAL SOLUTIONS