BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103535 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32492
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE
    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. THIS IS THE SAME PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH AMIKACIN (250MG, INTRAPERITONEALLY, FREQUENCY NOT REPORTED) FOR PERITONITIS. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584463 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R UNKNOWN BAXTER TRANSFER SET,| UNKNOWN BAXTER TITANIUM ADAPTER,| 2.5% DIANEAL PD2 ULTRABAG, EXTRANEAL