BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3082971 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10670
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE FOLLOWING INFORMATION WAS NOT INCLUDED IN THE INITIAL MDR: THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THE PATIENT WAS INITIALLY HOSPITALIZED FOR SEPTICEMIA AND SEPTIC SHOCK. WHILE HOSPITALIZED THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND SUFFERED A HEART ATTACK. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PERITONITIS AND SUBSEQUENTLY PASSED AWAY. THE PATIENT WAS TREATED WITH VANCOMYCIN, CEFAPIME AND ZITHROMAX (ROUTES, DOSES AND FREQUENCIES NOT REPORTED). ON AN UNKNOWN DATE DURING THE HOSPITALIZATION PERITONEAL DIALYSIS THERAPY WAS WITHDRAWN. THE PATIENT WAS DISCHARGED HOME UNDER HOSPICE CARE AND PASSED AWAY FOUR DAYS LATER. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE EXACT CAUSE OF DEATH WAS NOT REPORTED AS THE PATIENT WAS EXPERIENCING MANY SIGNIFICANT MEDICAL ISSUES AND WAS ON HOSPICE CARE AT HOME AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184641 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| H| R EXTRANEAL| DIANEAL LOW CA