BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3770543 · Received April 24, 2014

    Report

    Report Number
    1416980-2014-13196
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) PASSED AWAY DUE TO AN UNKNOWN CAUSE. THE PT WAS NOT HOSPITALIZED PRIOR TO DEATH. THE PT PASSED AWAY AT HOME. CAPD (CONTINUOUS AMBULATORY PD) THERAPY WAS ONGOING UNTIL THE TIME OF DEATH; HOWEVER, THE PT WAS NOT PERFORMING CAPD THERAPY AT THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250008 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death DIANEAL PD2, 4.25% ULTRABAG| DIANEAL PD2, 2.5% ULTRABAG