BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1841984 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03638
    Event Type
    Death
    Date Received
    September 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS FOR THE MINICAP DISCONNECT CAP (GD876490, GD874859 AND GD875575), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED 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 EPISODE IS UNKNOWN, THE SAMPLE WAS NOT REQUESTED.BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM OF PERITONITIS. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THESE PRODUCT LINES FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FEMORAL LOOSENING AND PELVIC OSTEOLYSIS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A HEALTHCARE PROFESSIONAL FROM THE USA OF FATAL PERITONITIS, FATAL SEPSIS, AND FATAL SEPTIC SHOCK IN AN APPROXIMATELY (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG AND DIANEAL PD2 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) AND DIANEAL PD2 ULTRABAG (DOSE, FREQUENCY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING HEALTHCARE PROFESSIONAL STATED THAT ON AN UNREPORTED DATE, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, SEPSIS, AND SEPTIC SHOCK. ON (B)(6)2010, THE PATIENT DIED. THE CAUSES OF DEATH WERE PERITONITIS, SEPSIS, AND SEPTIC SHOCK. THE HEALTHCARE PROFESSIONAL DID NOT PROVIDE INFORMATION REGARDING TREATMENT FOR THE EVENTS. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. DIANEAL THERAPIES WERE ONGOING AT THE TIME OF THE PATIENT'S DEATH. PER THE HEALTHCARE PROFESSIONAL, THE FATAL PERITONITIS, FATAL SEPSIS, AND FATAL SEPTIC SHOCK WERE NOT RELATED TO DIANEAL PD4 ULTRABAG OR DIANEAL PD2 ULTRABAG THERAPIES.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death DIANEAL PD2 ULTRABAG