BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3943625 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23211
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) PATIENT (PT) PASSED AWAY DUE TO AN UNKNOWN CAUSE. THREE DAYS PRIOR TO DEATH, THE PT WAS ADMITTED TO THE HOSPITAL FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PT WAS TRANSITIONED INTO HOSPICE CARE (DATE NOT REPORTED). THE PT THEN PASSED AWAY DUE TO AN UNKNOWN CAUSE. IT WAS UNKNOWN IF CAPD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS UNKNOWN IF THE PT WAS PERFORMING CAPD THERAPY WITH A BAXTER SOLUTION AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS 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
    422944 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death EXTRANEAL| DIANEAL PD2, 2.5% ULTRABAG| DIANEAL PD2, 4.25% ULTRABAG