BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4112296 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32954
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS (DOSE, ROUTE, FREQUENCY AND DURATION NOT REPORTED) FOR PERITONITIS. THERAPY WAS ONGOING. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS NOT RECOVERED AT THE TIME OF THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.THIS IS REPORT 2 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592619 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention PHYSIONEAL 2.5% AND PHYSIONEAL 4.25%| TRANSFER SET, TITANIUM ADAPTER,