BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2072170 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05150
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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 SECOND OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H10F01037, H10G12065 AND H10I30048 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE WAS DETERMINED AS AN EXIT SITE INFECTION. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE HP'S FAMILY REPORTED TO BAXTER THAT ON (B)(6) 2011, THE HP WAS WITHDRAWN FROM PERITONEAL DIALYSIS(PD) THERAPY FOR UNKNOWN REASONS, AND ON (B)(6) 2011, THE HP DIED AS A RESULT FROM THE PD WITHDRAWAL. ON (B)(6) 2011, THE PDRN CONFIRMED THE DEATH REPORT, AND STATED THAT ON (B)(6) 2011, THE HP WAS DIAGNOSED WITH A (B)(6) EXIT SITE INFECTION. THE CAUSE WAS UNKNOWN, BUT THE HP REPORTEDLY REFUSED TREATMENT FOR THE INFECTION WHICH DID NOT RESOLVE. ON (B)(6) 2011, THE HP WAS ALSO DIAGNOSED WITH (B)(6) PERITONITIS. IT WAS NOT REPORTED IF A PD EFFLUENT CULTURE WAS PERFORMED. THE REPORTER STATED THAT THE PERITONITIS AND EXIT SITE INFECTION EVENTS WERE NOT RELATED TO PD THERAPY.

    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 38 YR Death| O DIANEAL LOCAL(PD4) AMBUFLEX| HOME CHOICE CYCLER| DIANEAL LOCAL(PD4) ULTRABAG