BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3882001 · Received June 18, 2014

    Report

    Report Number
    1416980-2014-19412
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14C25021 AND H14A24135 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. 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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED INDICATION AND ON THE SAME DAY WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND DIARRHEA. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT BEGAN TREATMENT WITH FLAGYL (DAILY AND DOSE UNKNOWN) INTRAVENOUS (IV) FOR PERITONITIS. TREATMENT WITH FLAGYL WAS ONGOING. THE PATIENT WAS STILL HOSPITALIZED AND RECOVERING FROM THE PERITONITIS. DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358900 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R HOMECHOICE, CASSETTE, MINICAP, DIANEAL