BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2012472 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02965
    Event Type
    Death
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10B05029, H10F01037, AND H10H31055 WITH NO DEFECTS NOTED. ROOT CAUSE OF THE CLOUDY EFFLUENT, REPORTED SEPSIS AND SUBSEQUENT DEATH WAS UNDETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED IN THE COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 MEDWATCH REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF TWO REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE IN THE USA OF WHITE CLOUDY SUBSTANCE IN HER FLUID AND FATAL SEPSIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN BAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN BAG (LOT NUMBER, FREQUENCY, AND DOSE NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CLOUDY PERITONEAL FLUID. TREATMENT AND OUTCOME FOR THE CLOUDY PERITONEAL FLUID WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED SEPSIS. ON (B)(6) 2011, THE PATIENT DIED. THE NURSE REPORTED THE CAUSE OF DEATH AS SEPSIS. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF DEATH. CONCOMITANT MEDICATIONS WERE NOT REPORTED. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2011 FROM THE PD NURSE. THE PD NURSE REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 FOR CLOUDY EFFLUENT AND FOUL ODOR. NURSE REPORTED THE CLOUDY EFFLUENT AND FOUL ODOR WAS NOT RELATED TO PD. NURSE CLARIFIED THAT THE PATIENT DIED ON (B)(6) 2011 FROM SEPSIS. THE NURSE REPORTED THE ORIGIN OF THE SEPSIS AS UNKNOWN. THE EVENT OF FATAL SEPSIS WAS NOT RELATED TO PD THERAPY PER THE NURSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H DIANEAL