BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4090258 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31316
    Event Type
    Death
    Date Received
    September 15, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN; THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. 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 PASSED AWAY COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO RENAL FAILURE, SEPSIS AND CARDIAC FAILURE. THE CAUSE OF THE SEPSIS EVENT WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR AN UNKNOWN INDICATION AND SUBSEQUENTLY PASSED AWAY. TREATMENT WHILE HOSPITALIZED WAS UNKNOWN. IT WAS REPORTED THAT DURING HOSPITALIZATION PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568378 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| H DIANEAL PD4 4.25% AMBUFLEX,| TRANSFER SET, TITANIUM ADAPTER, CASSETTE,| DIANEAL PD4 2.5% AMBUFLEX, HOMECHOICE