BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103400 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32465
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 26, 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

    COMPLAINT NO: CMPLNT-(B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED SEPSIS AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO SEPSIS. THE CAUSE OF THE SEPSIS WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED INDICATION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED SEPSIS MANIFESTED BY FEVER, VOMITING AND DIARRHEA AND SUBSEQUENTLY PASSED AWAY. TREATMENT FOR THE EVENT OF SEPSIS WAS NOT REPORTED. PD THERAPY WAS REPORTED TO BE ONGOING. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584001 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| H 2.5% PHYSIONEAL, EXTRANEAL, 1.5% PHYSIONEAL| TRANSFER SET, TITANIUM ADAPTER