BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2111252 · Received June 2, 2011

    Report

    Report Number
    1423500-2011-06960
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 8, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 PATIENTS 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PERITONITIS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT OF DEATH OF A FEMALE PATIENT COINCIDENT WITH DIANEAL-N PD 4 1.5 FROM A FAMILY MEMBER OF THE PATIENT IN (B)(6). ON (B)(6) 2011, DURING A CALL WITH BAXTER (B)(4) TECHNICAL SERVICE CENTER THE FAMILY MEMBER REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2011. ON (B)(6) 2011 SUPPLEMENTAL INFORMATION WAS PROVIDED BY A PHYSICIAN: ON (B)(6) 2009, THE PATIENT BEGAN DIANEAL-N PD-4 1.5 (1500ML, IP, THREE TIMES A DAY) THERAPY FOR RENAL FAILURE CHRONIC. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED WITH COMPLAINT OF PHYSICAL DECONDITIONING. HER PERITONEAL EFFLUENT WAS A LITTLE CLOUDY DUE TO SUSPECTED PERITONITIS. THE PERITONITIS WAS NOT CONFIRMED. WITH SYMPTOMS OF PHYSICAL DECONDITIONING AND PERITONEAL CLOUDY EFFLUENT AN UNSPECIFIED ANTIBIOTICS THERAPY WAS STARTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND FECAL EFFLUENT. BOWEL PERFORATION WAS SUSPECTED BASED ON THESE SYMPTOMS BUT NOT DEFINITELY DIAGNOSED. THE PATIENT'S GENERAL HEALTH STATUS WAS GRADUALLY DECLINING. ON (B)(6) 2011, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS CARDIAC FAILURE. DIANEAL-N PD-4 1.5 THERAPY WAS ONGOING UNTIL HER DEMISE. THE REPORTING PHYSICIAN STATED THAT ALL THESE SEQUENCES WERE UNRELATED TO DIANEAL-N PD-4 1.5 WHICH THE PATIENT HAD BEEN SUCCESSFULLY TREATED WITH UP TO HER LAST MOMENT. THERE WAS NO ALLEGATION AGAINST ANY BAXTER DEVICE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL LOCAL(PD4) AMBUFLEX