BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1881782 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04880
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT, H10E25095, H10A28031, H09L29014, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF TWO COMPLAINTS FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE FROM A US NURSE INDICATING THAT A (B)(6) MALE PATIENT EXPERIENCED PERITONITIS ON AN UNKNOWN DATE. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING CONSUMER STATED THAT ON AN UNREPORTED DATE THE PATIENT WAS DIAGNOSED WITH PERITONITIS. DURING A FOLLOW-UP CALL ON (B)(6)2010, THE NURSE STATED THE PATIENT EXPIRED ON (B)(6)2010 OF PERITONITIS (CULTURE AND ORGANISM UNKNOWN). IT IS UNKNOWN WHAT LABS OR CULTURES WERE PERFORMED. IT IS UNKNOWN WHAT INTERVENTIONS WERE PROVIDED. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. THE PATIENT PREVIOUSLY REPORTED DISCOMFORT ON (B)(6)2010. THE NURSE INDICATED THE EVENT OF FATAL PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT'S DIALYSIS RN PROVIDED THE FOLLOWING INFORMATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 WITH PERITONITIS. PD THERAPY WITH THE CYCLER CONTINUED UNTIL THE DIAGNOSIS OF A BOWEL PERFORATION, WHERE AT THAT TIME PD THERAPY WAS DISCONTINUED. THE PATIENT WAS TREATED WITH VANCOMYCIN DOSE UNKNOWN FOR THE BOWEL PERFORATION ON (B)(6) 2010. HE WAS REPORTEDLY NOT A CANDIDATE FOR SURGERY. THE BAXTER SOLUTIONS AND PRODUCTS WERE NOT BELIEVED RELATED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death| H| R DIANEAL PD4 AMBUFLEX