BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1873342 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04592
    Event Type
    Death
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 26, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE, NO EVALUATION WAS PERFORMED. THE PRODUCT CODE WAS NOT REPORTED, THEREFORE THE 510K NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN INDICATES: THE EVENT OF DEATH WAS AMENDED TO SEPSIS AND PNEUMONIA. SUSPECTED PRODUCT (PREVIOUSLY REPORTED AS DIANEAL UNKNOWN) WAS SPECIFIED TO BE DIANEAL-N PD-2 1.5 TWIN BAG. ON (B)(6) 2010, THE PATIENT BEGAN DIANEAL-N PD-2 1.5 TWIN BAG THERAPY (DOSE AND FREQUENCY WERE NOT REPORTED) INTRAPERITONEALLY FOR RENAL FAILURE CHRONIC. THE CAUSES OF DEATH WERE SEPSIS AND PNEUMONIA. DIANEAL-N PD-2 1.5 THERAPY WAS ONGOING AT THE TIME OF DEATH. THE PHYSICIAN STATED THAT THE FATAL EVENTS OF SEPSIS AND PNEUMONIA WERE UNRELATED TO DIANEAL-N PD-2 1.5. THE PHYSICIAN BELIEVED THAT THE EVENT OF FATAL SEPSIS WAS DUE TO PNEUMONIA.

    Description of Event or Problem · 1

    THE BAXTER (B)(4) TECHNICAL SERVICE CENTER RECEIVED A CALL FROM A MALE PATIENT'S FAMILY INDICATING THE PATIENT HAD EXPIRED ON AN UNKNOWN DATE. ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL UNKNOWN THERAPY INTRAPERITONEALLY FOR CHRONIC RENAL FAILURE. ON (B)(6)2010, THE PATIENT'S FAMILY MEMBER CALLED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND REPORTED THAT THE PATIENT HAD EXPIRED ON AN UNREPORTED DATE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death DIANEAL THERAPY