BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4112033 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32928
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS REPORTED TO BE SEPTIC SHOCK. THE CAUSE OF THE BACTERIAL PERITONITIS EVENT WAS UNKNOWN. HOSPITALIZATION BEGAN ON THE SAME DAY AS THE BACTERIAL PERITONITIS DIAGNOSIS. ON THE DAY OF THE BACTERIAL PERITONITIS DIAGNOSIS, THE PATIENT WAS TREATED WITH VANCOMYCIN (1.5 GRAMS FOR 1 DOSE, INTRAPERITONEALLY (IP)) AND CEFTAZIDINE (1 GRAM FOR 1 DOSE, IP). TWO DAYS AFTER THE ONSET OF BACTERIAL PERITONITIS, THE PATIENT WAS TREATED WITH CEFAZOLIN (ROUTE, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED). IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERED FROM THE BACTERIAL PERITONITIS EVENT PRIOR TO PASSING AWAY. THE PATIENT PASSED AWAY AT THE HOSPITAL 17 DAYS AFTER BEING ADMITTED. ON AN UNREPORTED DATE DURING THE HOSPITALIZATION, PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590637 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| H| R TITANIUM ADAPTER, CASSETTE, MINICAP| DIANEAL 1.5% PD4 SINGLEBAG, HOMECHOICE,