BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4182891 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36409
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY, MANIFESTED BY NAUSEA, VOMITING AND CLOUDY FLUID. THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHILE HOSPITALIZED FOR AN UNRELATED EVENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL CEFAZOLIN (DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. THERAPY WAS ONGOING. FIVE DAYS AFTER BEING ADMITTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE CEFAZOLIN WAS ONGOING. THE REPORTER STATED THE PERITONITIS WAS HOSPITAL ACQUIRED; HOWEVER, THE EXACT CAUSE OF THE PERITONITIS IS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662352 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1.5% DIANEAL PD4 AMBUFLEX, HOMECHOICE| TRANSFER SET, MINICAP, CASSETTE,