BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3781978 · Received April 30, 2014

    Report

    Report Number
    1416980-2014-14004
    Event Type
    Death
    Date Received
    April 30, 2014
    Report Date
    December 26, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE WAS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). TYPE OF STUDY: OBSERVATIONAL. THE EVENTS OCCURRED DURING A NON-BAXTER STUDY INITIATED BY A PHYSICIAN IN (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED A SEVERE INFECTION AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. TREATMENT WAS NOT REPORTED. THE CAUSE OF THE SEVERE INFECTION WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THE CAUSE OF DEATH WAS REPORTED AS DUE TO THE SEVERE INFECTION. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259233 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LOW CALCIUM SOLUTION (LACTATE- G1.5%)