BEUDAMED
    FDA Adverse Event Death Summary report: N

    REN - HARDWARE

    MDR report key: 1915126 · Received December 6, 2010

    Report

    Report Number
    1423500-2010-06569
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INTERNATIONAL COMPLAINT OWNER HAS NOTIFIED WRITER THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE SERIAL NUMBER IS UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND SERIAL NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE IS UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REQUEST FROM A CALLER TO PICK UP THE HOMECHOICE CYCLER AND THERAPY SUPPLIES AS THE PATIENT PASSED AWAY. THIS IS A SPONTANEOUS REPORT OF DEATH IN A MALE PATIENT COINCIDENT WITH DIANEAL BY A CONSUMER FROM (B)(6). ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL THERAPY (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR CHRONIC RENAL FAILURE. ON (B)(6) 2010, THE CALLER CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND REPORTED THAT THE PATIENT HAD EXPIRED. THE REPORTER DID NOT PROVIDE THE CAUSE AND EXACT DATE OF DEMISE, OR WHETHER TREATMENT WAS RENDERED TO THE PATIENT PRIOR TO THE EVENT. THE CALLER DID NOT COMMENT ON CAUSALITY BETWEEN THE EVENT OF DEATH AND DIANEAL. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ADDITIONAL INFORMATION OBTAINED FROM A PHYSICIAN ON 15NOV2010 IS AS FOLLOWS: THE PATIENT WAS IN HIS (B)(6). IN (B)(6) 2010, THE PATIENT BEGAN DIANEAL-N PD-4 2.5 THERAPY (2000ML, IP, THREE TIMES A DAY) FOR CHRONIC RENAL FAILURE. IN (B)(6) 2010, DIANEAL-N PD-4 THERAPY WAS WITHDRAWN. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT EXPIRED. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED, WHETHER DIANEAL-N PD-4 THERAPY WAS ONGOING AT THE PATIENT'S DEMISE, OR THE CAUSE OF DEATH. MEDICAL HISTORY INCLUDED DIABETES AND CARDIAC FAILURE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN STATED THAT THE EVENT OF DEATH WAS UNRELATED TO DIANEAL-N PD-4. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death DIANEAL-N PD-4 2.5