BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3130179 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13381
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE USE ERROR BECAUSE THE NURSE REPORTED THAT THE PATIENT'S TRANSFER SET GOT CAUGHT ON A BOX, WHICH RESULTED IN THE TRANSFER SET BEING PULLED OUT, WHICH CAUSED THE PERITONITIS. THE INSTRUCTIONS LISTED IN THE PATIENT AT HOME GUIDE FOR THE HOMECHOICE DEVICE INSTRUCTS THE USER TO FOLLOW ASEPTIC TECHNIQUE WHEN HANDLING LINES AND SOLUTION BAGS TO REDUCE THE POSSIBILITY OF INFECTION. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF PERITONITIS IS UNKNOWN. UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE THE PATIENT EXPERIENCED PERITONITIS. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THAT THE PATIENT GOT THEIR TRANSFER SET CAUGHT ON A BOX AND PULLED THE TRANSFER SET OUT. ON AN UNKNOWN DATE THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS AND TREATED WITH VANCOMYCIN AND CEFEPIME INTRAPERITONEALLY (IP) (DOSES AND FREQUENCIES NOT REPORTED). THERE WAS NO ISSUE WITH THE CATHETER. THE NURSE REPORTED THAT THE TRANSFER SET BEING PULLED OFF WAS WHAT CAUSED THE PERITONITIS. THE TRANSFER SET WAS REPLACED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231079 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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