BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP

    MDR report key: 2072153 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05149
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    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 THIRD OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS GD880799 WITH DEFECTS NO DEFECTS NOTED. 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    ON (B)(6) 2011, THE HP'S FAMILY REPORTED TO BAXTER THAT ON (B)(6) 2011, THE HP WAS WITHDRAWN FROM PERITONEAL DIALYSIS(PD) THERAPY FOR UNKNOWN REASONS, AND ON (B)(6) 2011, THE HP DIED AS A RESULT FROM THE PD WITHDRAWAL.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 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death| O DIANEAL LOCAL( PD4) ULTRABAG| DIANEAL LOCAL(PD4) AMBUFLEX| HOME CHOICE CYCLER