BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1813368 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02848
    Event Type
    Death
    Date Received
    August 24, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT DISCARDED SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PATIENT'S FAMILY FROM (B)(6) OF DEATH IN A FEMALE PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5% AND EXTRANEAL THERAPIES. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-4 1.5% AND EXTRANEAL THERAPIES. ON 29JUL2010, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT THE PATIENT HAD DIED. CAUSE OF DEATH AND CAUSALITY WERE NOT PROVIDED. THE PATIENT'S PHYSICIANS AND NURSE DID NOT KNOW OF THE PATIENT'S DEATH AND GUESSED THAT THE PATIENT HAD DIED AT ANOTHER HOSPITAL. ADDITIONAL INFORMATION IS NOT EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O