BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4888068 · Received July 2, 2015

    Report

    Report Number
    1416980-2015-27547
    Event Type
    Death
    Date Received
    July 2, 2015
    Report Date
    June 15, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY DUE TO AN UNREPORTED CAUSE COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. SIX DAYS PRIOR TO DEATH, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. THE PATIENT WAS ON HEMODIALYSIS THERAPY DURING HOSPITALIZATION. SUBSEQUENTLY DURING HOSPITALIZATION, THE PATIENT PASSED AWAY DUE TO AN UNREPORTED CAUSE. IT WAS NOT REPORTED WHETHER THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430710 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL PD4, 1.5%, 2.5%, 4.25% AMBUFLEX| HOMECHOICE