BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTENSION SET

    MDR report key: 2200876 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10554
    Event Type
    Death
    Date Received
    August 11, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (H11D28059 AND H11D05040) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE THIRD OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT DEATH. PER THE INITIAL REPORT, THE CAREGIVER (CG) REPORTED THE HOME PATIENT (HP) PASSED AWAY LAST WEEK. ON (B)(6) 2011, BAXTER SPOKE TO THE PERITONEAL DIALYSIS NURSE (PDRN) WHO CONFIRMED THAT THE HP DIED ON (B)(6) 2011. THE CAUSE OF DEATH WAS UNKNOWN AT THE TIME OF THIS REPORT. THE PDRN STATED THE DEATH WAS UNRELATED TO THE BAXTER PD PRODUCTS. ON (B)(6) 2011, A BAXTER CLINICIAN SPOKE WITH THE HP'S WIFE WHO STATED THAT THE HP'S PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING AT THE TIME OF DEATH. ON (B)(6) 2011, THE HP BECAME SICK VERY SUDDENLY WITH COMPLAINTS OF CONSTIPATION AND ABDOMINAL PAIN. THEY WENT TO THE EMERGENCY ROOM FOR AN EVALUATION AND ADMITTED THAT SAME DAY WITH A DIAGNOSIS OF PERITONITIS AND CONSTIPATION. CULTURE RESULTS AND TREATMENT WERE UNKNOWN. ON (B)(6) 2011, WHILE STILL HOSPITALIZED, THE HP DIED VERY SUDDENLY AS HE WAS HAVING A CONVERSATION WITH FAMILY AT THE BEDSIDE. THE WIFE STATED THAT THE CAUSE OF DEATH WAS PERITONITIS AND CONSTIPATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death| H| R EXTRANEAL ICODEXTRIN| HOME CHOICE| LOCAL(PD4) AMBUFLEX