BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4192468 · Received October 22, 2014

    Report

    Report Number
    1416980-2014-36895
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    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 TRANSFER SET. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SUSPECTED FUNGAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE SUSPECTED FUNGAL PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE SUSPECTED FUNGAL PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTIC(S) (MEDICATION, DOSAGE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) AND UNKNOWN ANTIFUNGAL THERAPY (MEDICATION, DOSAGE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) 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 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672095 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

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