BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4250591 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40526
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH CEFAZOLIN, (IP) INTRAPERITONEALLY, 250 (MG) MILLIGRAMS, (FOUR TIMES A DAY) AND CEFTAZIDIME, IP, 250 MG (FOUR TIMES A DAY). AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED AND THE TREATMENT WITH CEFAZOLIN AND CEFTAZIDIME WAS ONGOING. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS NOT YET RESOLVED, AND THE PATIENT WAS NOT RECOVERED FROM THE EVENT. TEN DAYS AFTER ONSET, EXTRANEAL AND PHYSIONEAL THERAPIES WERE WITHDRAWN, THE PATIENT¿S PD CATHETER WAS REMOVED AND THE PATIENT STARTED HEMODIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738688 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R PHYSIONEAL, EXTRANEAL, TITANIUM ADAPTER, MINICAP