BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3972962 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25015
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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 THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS THERAPY WHICH RESULTED IN THE DEVELOPMENT OF BACTERIAL PERITONITIS. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT LEFT A FAN ON DURING DIALYSIS TREATMENT. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND TREATED WITH INTRAPERITONEAL CEFEPIME DAILY (DOSE NOT REPORTED). IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. AFTER EIGHT DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS WITH ONGOING ANTIBIOTIC TREATMENT. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451447 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R EXTRANEAL VIAFLEX, HOMECHOICE| DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX| DIANEAL 1.5% AND 2.5% PD4 ULTRABAG