BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1941648 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07392
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOTS, H10B26041 AND H10D30064, 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) - AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS IS THE FIRST OF FOUR COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE CONSUMER STATED THAT ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED CARDIAC FAILURE AND ON (B)(6) 2010, DIED. TREATMENT INFORMATION WAS NOT PROVIDED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE PATIENT'S DEATH. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF FATAL CARDIAC FAILURE AND DIANEAL PD4 AMBUFLEX THERAPY. FURTHER INFORMATION WAS OBTAINED 15DEC2010 FROM THE DIALYSIS NURSE. ACCORDING TO THE CHART, THE CAUSE OF DEATH WAS NOTED AS COMPLICATIONS DUE TO FUNGAL PERITONITIS. ACCORDING TO THE NURSE, THE EVENT OF FATAL COMPLICATIONS DUE TO FUNGAL PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| O DIANEAL PD4 AMBUFLEX