BEUDAMED
    FDA Adverse Event Death Summary report: N

    1423500-2010-07414

    MDR report key: 1942399 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07414
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. SAMPLE AVAILABILITY WAS UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. AS MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORTED EVENT OF PATIENT DEATH IS NOT ATTRIBUTED TO OR BELIEVED TO BE CAUSED BY A DISPOSABLE DEVICE PRODUCT FAILURE ACCORDING TO THE INFORMATION PROVIDED. NO DEVICE CAUSE CAN BE DETERMINED DUE TO INSUFFICIENT INFORMATION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE AND A PHYSICIAN FROM (B)(6) OF PNEUMONIA AND SUBSEQUENT DEATH OF A PATIENT. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-4 2.5% AND EXTRANEAL THERAPIES. ON (B)(6) 2010, THE NURSE CONTACTED BAXTER (B)(4) AND STATED THAT THE PATIENT HAD DIED. UPON FOLLOW-UP, THE PHYSICIAN STATED THAT THE PATIENT (B)(6) HAD A HEART DISORDER AS COMPLICATION. THE PHYSICIAN BELIEVED THAT THE FATAL EVENT WAS NOT RELATED TO PD THERAPY, DUE TO THE CAUSE OF DEATH BEING PNEUMONIA. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FKX UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL-N PD-4 2.5%| EXTRANEAL.