BEUDAMED
    FDA Adverse Event Death Summary report: N

    REN - HARDWARE

    MDR report key: 1941646 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07390
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 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). THE DEVICE REPORTED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. BASED ON AVAILABLE INFORMATION 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)- BAXTER US HAS REQUESTED AN EVALUATION OF THE DEVICE FROM THE INTERNATIONAL AFFILIATE, BUT THE DEVICE LOCATION IS UNKNOWN AT THIS TIME. AS FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A CALL FROM A PATIENT'S FAMILY MEMBER (B)(6) 2010 WHO CALLED FOR ASSISTANCE AND REPORTED THE PATIENT'S DEATH. IT IS DOCUMENTED THAT THE PATIENT WAS RECEIVING PD THERAPY AT THE TIME OF DEATH. THE FOLLOWING INFORMATION WAS RECEIVED ON 09DEC2010 FROM A (B)(6) PHYSICIAN. THE PATIENT BEGAN PERITONEAL DIALYSIS(PD) THERAPY (B)(6) 2007. IN (B)(6) 2008, THE PATIENT BEGAN USING DIANEAL-N PD4 2.5% AND EXTRANEAL FOR PD THERAPY. THE PHYSICIAN STATED THAT THE CAUSE OF DEATH WAS FATAL ACUTE CARDIAC FAILURE. EXTRANEAL WAS NOT SUSPECTED. THE PATIENT DID NOT RECEIVE TREATMENT FOR HER FATAL EVENT. THE PHYSICIAN STATED THAT THE PD THERAPY WAS NOT RELATED TO HER DEATH. RATHER HER RISK FACTORS, WHICH SHE HAD BEFORE THE INITIATION OF PD THERAPY, COULD CAUSE SUCH AN EVENT.

    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 84 YR Death EXTRANEAL| DIANEAL