BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4111711 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32874
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4) SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE DAY FOLLOWING THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE BACTERIAL PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH CIPROFLOXACIN ORALLY (DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE BACTERIAL PERITONITIS EVENT. BEGINNING TWO DAYS AFTER THE ONSET OF BACTERIAL PERITONITIS, THE PATIENT WAS TREATED WITH CEFTAZIDIME (1.5 GRAM, INTRAPERITONEALLY (IP), DAILY) FOR THE BACTERIAL PERITONITIS EVENT. ANTIBIOTIC THERAPY WITH CIPROFLOXACIN WAS REPORTED TO BE ONGOING AT THE TIME OF THIS REPORT. ANTIBIOTIC THERAPY WITH CEFTAZIDIME COMPLETED AFTER 24 DAYS. AFTER THREE DAYS OF HOSPITALIZATION FOR THE BACTERIAL PERITONITIS EVENT, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592071 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R DIANEAL 1.5% AND 2.5%,| TITANIUM ADAPTER, CASSETTE, MINICAP, HOMECHOICE