BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4123582 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33522
    Event Type
    Death
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(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 CMPLNT-(B)(4), CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY DIED COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS THERAPY. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (INTRAVENOUSLY, DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. THE PATIENT SUBSEQUENTLY DIED. THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO SEPTIC SHOCK AND END STAGE KIDNEY FAILURE. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602222 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R DIANEAL 2.5% AND 4.25% AMBUFLEX, PD4, EXTRANEAL| TRANSFER SET, CASSETTE, TITANIUM ADAPTER