BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4192469 · Received October 22, 2014

    Report

    Report Number
    1416980-2014-36894
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT (PT) EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT OF PERITONITIS. THE CAUSE OF THE PERITONITIS WAS THOUGHT TO BE FUNGAL, BUT THIS WAS NOT CONFIRMED. ON AN UNKNOWN DATE DURING HOSPITALIZATION, THE PERITONEAL DIALYSIS (PD) CATHETER WAS REMOVED AND THE PT WAS PLACED ON IN CENTER HEMODIALYSIS. ON AN UNREPORTED DATE, DIANEAL AND EXTRANEAL THERAPIES WERE DISCONTINUED. ON AN UNKNOWN DATE THE PT BEGAN TREATMENT WITH AN UNKNOWN ANTIBIOTIC AND UNKNOWN ANTIFUNGAL (ROUTE, DOSE, FREQUENCY UNKNOWN). ON AN UNKNOWN DATE, THE PT WAS DISCHARGED FROM THE HOSPITAL. THE PT REMAINS ON HEMODIALYSIS AND WILL MOST LIKELY NOT RETURN TO PD THERAPY FOR THE NEXT 4-5 MONTHS. THE PT IS RECOVERING FROM THE EVENT OF PERITONITIS. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672634 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL 1.5%, 2.5%, AND 4.25% ULTRABAG| DIANEAL 2.5% AND 4.25% SINGLEBAG, EXTRANEAL| TRANSFER SET, CASSETTE, MINICAP, HOMECHOICE