BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4150296 · Received October 7, 2014

    Report

    Report Number
    1416980-2014-34944
    Event Type
    Death
    Date Received
    October 7, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER FOLLOW UP IT WAS LEARNED THAT THE PATIENT WAS A CONTINUOUS AMBULATORY PERITONEAL DIALYSIS PATIENT (PD) THERAPY PATIENT USING BAXTER DISPOSABLE PRODUCTS ONLY. THE CAUSE OF DEATH WAS HEART FAILURE (PREVIOUSLY THE CAUSE OF DEATH WAS NOT REPORTED). IT WAS REPORTED THAT THE PATIENT WAS HAVING CHEST PAINS AND WAS BROUGHT TO THE EMERGENCY ROOM WHERE HE PASSED AWAY. HE WAS NOT GIVEN ANY TREATMENT. IT WAS STATED THAT THE PATIENT HAD THEIR LAST PD THERAPY ONE HOUR BEFORE PASSING WHILE IN THE HOSPITAL EMERGENCY ROOM. THEREFORE AS THERE IS NO REPORT OF CONTAMINATION, ALLERGEN EXPOSURE, OR UNINTENDED COMPONENT INTERACTIONS IN ASSOCIATION WITH THIS DEATH, BAXTER DISPOSABLES ARE NO LONGER CONSIDERED SUSPECT PRODUCT IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629737 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death