BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4063621 · Received September 5, 2014

    Report

    Report Number
    1416980-2014-29746
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INJECTION REFLIN (1G PER DAY, ROUTE NOT REPORTED), INJECTION TOBRAMYCIN (40MG PER DAY, ROUTE NOT REPORTED), AND INJECTION HEPARIN (25000 IU X 5ML, 3 TIMES PER DAY, ROUTE NOT REPORTED) FOR THE PERITONITIS. IT WAS NOT SPECIFIED IF THE PATIENT WAS RECOVERING FROM THE PERITONITIS. ANTIBIOTIC TREATMENT WAS ONGOING. ACTION TAKEN WITH PERITONEAL DIALYSIS THERAPY WAS NOT REPORTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544999 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXTRANEAL, TITANIUM ADAPTER, TRANSFER SET