BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1983723 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01731
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEATH COMPLAINT IS BEING REPORTED UNDER AN UNKNOWN DISPOSABLE AS IT WAS NOT REPORTED WHETHER THE PATIENT USED THE HOME CHOICE CYCLER FOR PERITONEAL DIALYSIS(PD)THERAPY AND THERE WERE NO RECORDS IN THE BAXTER DATABASE TO CONFIRM THE PATIENT'S USE OF THE CYCLER. THE CAUSE OF DEATH AS REPORTED BY THE PHYSICIAN WAS UNDETERMINED. THERE WAS NO ALLEGATION AGAINST ANY PRODUCT AND THERE WAS NOT ENOUGH INFORMATION TO DETERMINE WHETHER A BAXTER PRODUCT COULD HAVE CAUSED OR CONTRIBUTED TO THIS DEATH. THERE WAS NO FURTHER INFORMATION AVAILABLE. THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT BY A NURSE FROM (B)(6) OF DEATH IN A MALE PATIENT (AGE UNKNOWN) COINCIDENT WITH DIANEAL PD THERAPY. ON AN UNKNOWN DATE, HE WAS HOSPITALIZED FOR UNKNOWN REASON. ON (B)(6) 2011, THE NURSE FROM THE HOSPITAL CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND ASKED FOR CANCELATION OF DRUG DELIVERY DUE TO THE PATIENT DEATH. THE CAUSE OF DEATH AND THE CAUSALITY WERE NOT REPORTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. FOLLOW-UP INFORMATION WAS RECEIVED FROM A PHYSICIAN ON (B)(6) 2011. THE PATIENT WAS IN HIS 60'S WHEN THE EVENT OCCURRED. . AT THE END OF (B)(6) 2011, HE WAS ADMITTED TO ANOTHER HOSPITAL DUE TO CHECKUP FOR THE HEART DISORDER. IT WAS REPORTED THAT THE HEART DISORDER WAS NOT AGGRAVATED. ON (B)(6) 2011, WHILE HOSPITALIZED AND HE PASSED AWAY. THE PHYSICIAN ASSUMED THE CAUSE OF DEATH WAS POSSIBLY MYOCARDIAL INFARCTION OR CEREBRAL INFARCTION, BUT THE CAUSE OF DEATH WAS NOT CLEARLY SPECIFIED. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE PHYSICIAN CONSIDERED THAT ALL THE EVENTS WERE NOT RELATED TO DIANEAL N AND EXTRANEAL THERAPIES SINCE THE PATIENT HAD HAD MEDICAL HISTORY OF HEART DISORDER, WHICH WAS CONSIDERED AS A RISK FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL N PD-4 2.5%| DIANEAL N PD-4 1.5%| EXTRANEAL