BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2110208 · Received June 1, 2011

    Report

    Report Number
    1423500-2011-06902
    Event Type
    Death
    Date Received
    June 1, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT RETURNED THEREFORE NO EVALUATION WAS PERFORMED. THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PATIENT'S FAMILY FROM (B)(6) OF DEATH IN A FEMALE PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5% THERAPY. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-4 1.5% THERAPY. ON (B)(6) 2011, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT THE PATIENT HAD EXPIRED THAT DAY. CAUSE OF DEATH AND CAUSALITY WERE NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. FOLLOW-UP INFORMATION WAS MADE BY A PHYSICIAN ON (B)(6) 2011. THE PATIENT WAS IN HER 60'S. ON (B)(6) 2009, SHE BEGAN DIANEAL-N PD-4 1.5% THERAPY. ON (B)(6) 2011, SHE WAS TAKEN TO THE HOSPITAL. THE PATIENT REPORTEDLY EXPERIENCE CARDIAC AND RESPIRATORY ARREST AT THAT TIME. RESUSCITATION WAS ATTEMPTED WITHOUT SUCCESS. AN AUTOPSY WAS NOT PERFORMED. THE PHYSICIAN CONSIDERED THE CAUSE OF DEATH AS POSSIBLE MYOCARDIAL INFARCTION. THE PHYSICIAN BELIEVED DEATH WAS UNRELATED TO PD THERAPY. THE PATIENT HAD NO SYMPTOMS OF CARDIAC HYPERTROPHY. NO FURTHER INFORMATION IS ANTICIPATED FROM THE PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| R DIANEAL 4.15%