BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4090265 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31319
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 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 ANALYSIS 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 PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (2G, FREQUENCY, ROUTE, AND DURATION NOT REPORTED) AND INJECTION GENTAMYCIN (50MG, FREQUENCY, ROUTE, AND DURATION NOT REPORTED) FOR PERITONITIS. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568417 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DIANEAL 2.5% ULTRABAG, TITANIUM ADAPTER| TRANSFER SET