BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 7709747 · Received July 23, 2018

    Report

    Report Number
    1416980-2018-04521
    Event Type
    Death
    Date Received
    July 23, 2018
    Report Date
    July 23, 2018
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HOF H., AMANN V., TAUBER C., PAULUN A., "PERITONITIS IN A NEONATE DUE TO CYBERLINDNERA FABIANII, AN ASCOMYCETIC YEAST INFECTION". (2017 DEC) :1-4, DOI:10.1007/S15010-017-1062-8. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED FUNGAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS AND MULTIPLE OTHER INDICATIONS. THE PATIENT WAS TREATED WITH PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (75MG/KG EVERY 12 HOURS), AMPHOTERICIN B (3 MG/KG DAILY), FLUCONAZOLE AND CASPOFUNGIN ACETATE (14 MG, DAILY) FOR THE PERITONITIS (NO FURTHER DETAILS).SUBSEQUENTLY THE PATIENT EXPERIENCED SEPTIC SHOCK AND WAS TREATED WITH VANCOMYCIN, FLUCONAZOLE AND MEROPENEM FOR THE EVENT (NO FURTHER DETAILS). THE CAUSE OF THE SEPTIC SHOCK WAS REPORTED AS DUE TO THE FUNGAL PERITONITIS. IT WAS REPORTED THE PATIENT EXPERIENCED RESISTANCE TO THE FLUCONAZOLE AND CASPOFUNGIN ACETATE. ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO MULTI ORGAN FAILURE, CAPILLARY LEAK SYNDROME, SEPTIC SHOCK AND PERITONITIS. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553748 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DA Death| H| R