BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4201895 · Received October 27, 2014

    Report

    Report Number
    1416980-2014-37496
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH FORTAZ AND ANCEF INTRAPERITONEALLY (DOSES AND FREQUENCIES NOT REPORTED) FOR 21 DAYS FOR THE PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER FIVE DAYS AND REPORTED TO BE RECOVERING FROM THE PERITONITIS. THE PATIENT HAD NOT YET BEEN RETRAINED ON PROPER ASEPTIC TECHNIQUE. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682869 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R DIANEAL PD4 AMBUFLEX