BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2044239 · Received April 7, 2011

    Report

    Report Number
    1423500-2011-04192
    Event Type
    Death
    Date Received
    April 7, 2011
    Report Date
    March 17, 2011
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT'S DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW UP REPORT SHALL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE AND/OR UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW-UP INFORMATION RECEIVED FROM BY A NURSE IN (B)(6).THE PATIENT WAS IN HER (B)(6) AND HAD A DIAGNOSIS OF LUNG CANCER BEFORE PD THERAPY HAD BEGUN. UNSPECIFIED TREATMENT WAS ADMINISTERED FOR THE LUNG CANCER. ON (B)(6) 2011, THE PATIENT DIED OF METASTASIS TO MULTIPLE ORGANS DUE TO THE LUNG CANCER. PD THERAPY WAS ONGOING UNTIL HER DEATH. THE NURSE BELIEVED THAT THE FATAL EVENT WAS NOT RELATED TO PD THERAPY. PER THE ADDITIONAL INFORMATION WAS RECEIVED, THE DEVICE WAS DETERMINED NOT TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE HOME PATIENT'S (HP) DAUGHTER CONTACTED BAXTER (B)(6) AND STATED THAT THE HP HAD DIED. THE CAUSE OF DEATH AND CAUSALITY WERE NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ON (B)(6) 2011, FOLLOW-UP INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL. THE PD SOLUTIONS THAT THE HP HAD USED WERE DIANEAL-N PD-1.5% (2L, 2/1DAY) AND EXTRANEAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death HOME CHOICE CYCLER| DIANEAL-N LOCAL (PD2)| EXTRANEAL