BEUDAMED
    FDA Adverse Event Death Summary report: N

    REN - HARDWARE

    MDR report key: 1910815 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06369
    Event Type
    Death
    Date Received
    November 30, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 24, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO (B)(4) THEREFORE NO EVALUATION WAS PERFORMED. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED TO THE US FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A CALL WAS RECEIVED FROM A (B)(6) FAMILY REQUESTING PICK UP OF SUPPLIES AS THE (B)(6) FEMALE PATIENT HAD EXPIRED. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL UNKNOWN THERAPY. THE CAUSE OF DEATH AND THE CAUSALITY WERE NOT REPORTED. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE PHYSICIAN PROVIDED ADDITIONAL INFORMATION: PATIENT REPORTEDLY EXPIRED DUE TO CARDIAC FAILURE. ON (B)(6) 2006, THE PATIENT BEGAN DIANEAL-N PD-4 1.5 THERAPY. ON (B)(6) 2010, SHE DIED DUE TO CARDIAC FAILURE. SHE WAS TREATED WITH AN UNSPECIFIED MEDICATION FOR THE FATAL EVENT. DIANEAL N THERAPY WAS ONGOING UNTIL THE TIME OF DEATH WITHOUT ANY PROBLEMS. THE PHYSICIAN CONSIDERED THAT THE FATAL EVENT WAS NOT RELATED TO DIANEAL N THERAPY SINCE IT WAS DUE TO HER ADVANCED AGE AND THE MEDICAL HISTORY OF CARDIAC FAILURE. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R