BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1881783 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04881
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    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, GD874859, 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). THIS IS THE SECOND OF TWO REPORTS RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFOR NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF TWO COMPLAINTS RELATED TO THIS EVENT.

    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 FACILITY NURSE 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) RELATED TO THE BOWEL PERFORATION ON (B)(6) 2010. THE PATIENT WAS NOT A CANDIDATE FOR HEMODIALYSIS. BAXTER PRODUCTS AND SOLUTIONS WERE NOT BELIEVED TO BE RELATED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

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