BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3562425 · Received January 8, 2014

    Report

    Report Number
    1416980-2014-00910
    Event Type
    Death
    Date Received
    January 8, 2014
    Date of Event
    November 20, 2013
    Report Date
    December 15, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED A DISCONNECTION OF THE TRANSFER SET AND TITANIUM ADAPTER, WHICH LED TO PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT WAS TREATED WITH AN INTRAPERITONEAL (IP) INJECTION OF VANCOMYCIN, 1GM, AN INJECTION OF FORTUM 1 GM, AND A STAT IP INJECTION OF REFLIN 1 GM (FREQUENCIES WERE NOT REPORTED). ON AN UNKNOWN DATE, THE PATIENT RECOVERED FROM PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT DIED. THE CAUSE OF DEATH WAS A HEART ATTACK. 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
    14386 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R DIANEAL 1.5% AND 2.5% ULTRABAG