BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3802638 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14958
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 (PD) THERAPY, WHICH CAUSED PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT WITH ONGOING ANTIBIOTIC TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281969 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R 1.5% AND 2.5% DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX, DIANEAL ULTRABAG