BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4133532 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-34072
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP 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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS TREATED WITH INJECTION REFLIN (1G, DAILY, ROUTE AND DURATION NOT REPORTED), INJECTION TOBRAMYCIN (40MG, ONE DAILY, ROUTE AND DURATION NOT REPORTED), AND INJECTION HEPARIN (DOSE, ROUTE, DURATION, AND FREQUENCY NOT REPORTED) FOR PERITONITIS. THE CAUSE OF THE EVENT WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613298 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention TRANSFER SET, TITANIUM ADAPTER, EXTRANEAL| DIANEAL 1.5 % ULTRABAG, DIANEAL 2.5% ULTRABAG