BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4161946 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35277
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED DURING FOLLOW UP THAT THE CAUSE OF DEATH WAS DUE TO A MYOCARDIAL INFARCTION. DIANEAL PD2 ULTRABAG THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERITONITIS WAS MANIFESTED BY LOWER ABDOMINAL PAIN. THE DAY AFTER THE EVENT THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE PATIENT WAS TREATED WITH INTRAVENOUS VANCOMYCIN (DOSE, FREQUENCY, AND DURATION NOT REPORTED), ANCEF (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED), AND FORTAZ (DOSE, ROUTE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. ON AN UNKNOWN DATE, THE TREATMENT WAS CHANGED TO INTRAPERITONEAL AMPICILLIN (DOSE, FREQUENCY, AND DURATION NOT REPORTED) AND INTRAPERITONEAL GENTAMICIN (DOSE, FREQUENCY, AND DURATION NOT REPORTED) FOR PERITONITIS. EIGHT DAYS AFTER THE EVENT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND TRANSFERRED TO A CRITICAL CARE FACILITY. TEN DAY AFTER THE EVENT, THE PATIENT SUFFERED A CARDIAC ARREST. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL AND THE PATIENT PASSED AWAY. IT WAS REPORTED THE CAUSE OF DEATH WAS CARDIAC ARREST; HOWEVER, IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THE PERITONITIS WAS RESOLVED PRIOR TO DEATH. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644235 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H TITANIUM ADAPTER, MINICAP| DIANEAL 2.5% ABD 4.25% ULTRABAG,| CASSETTE| DIANEAL 2.5% AND 4.25% AMBUFLEX,