BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4232658 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39139
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH INJECTION VANCOMYCIN (500 MG, FREQUENCY AND ROUTE NOT REPORTED) AND INJECTION REFLIN (500 MG, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. THE OUTCOME OF THE PERITONITIS EVENT WAS UNKNOWN. SEVEN DAYS AFTER HOSPITALIZATION, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE SUDDEN CARDIAC ARREST. IT WAS UNKNOWN IF DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712566 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death| H| R 1.5% DIANEAL ULTRABAG, 2.5% DIANEAL ULTRABAG,| TITANIUM ADAPTER, TRANSFER SET