BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2099711 · Received May 23, 2011

    Report

    Report Number
    1423500-2011-06394
    Event Type
    Death
    Date Received
    May 23, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    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 PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSIGNABLE CAUSE OF THE REPORTED CONDITION IS UNKNOWN. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. CORRECTION: THERE WAS NO REPORT OF PERITONITIS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PATIENT'S FAMILY FROM (B)(6) OF DEATH IN A FEMALE PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5%, 2.5% AND EXTRANEAL THERAPIES. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD-4 1.5%, 2.5% AND EXTRANEAL THERAPIES. ON (B)(6) 2011, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT THE PATIENT HAD DIED. CAUSE OF DEATH AND CAUSALITY WERE NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ON (B)(6) 2011, THE PATIENT'S PHYSICIAN REPORTED THAT ON (B)(6) 2011, THE PATIENT PASSED AWAY FROM A MYOCARDIAL INFARCTION. THE PHYSICIAN BELIEVED THAT THE FATAL EVENT WAS NOT RELATED TO PD THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL LOCAL (PD4) ABMBUFLEX