BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7345366 · Received March 16, 2018

    Report

    Report Number
    1416980-2018-01392
    Event Type
    Injury
    Date Received
    March 16, 2018
    Report Date
    March 16, 2018
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FRANCONIERI, F., BONHOME, J., DORIOT, A., BONNAMY, C., FICHEUX, M., LOBBEDEZ, T. AND BECHADE, C. "FUNGAL PERITONITIS CAUSED BY RHODOTORULA MUCILAGINOSA IN A CAPD PATIENT TREATED WITH LIPOSOMAL AMPHOTERICIN B: A CASE REPORT AND LITERATURE REVIEW". PERITONEAL DIALYSIS INTERNATIONAL, VOLUME 38 (JAN-FEBRUARY 2018): 69-73. THE PERITONITIS OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2016. 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 CONTINUOUS AMBULATORY PERITONEAL DIALYSIS PATIENT EXPERIENCED FUNGAL PERITONITIS ALSO REPORTED AS A PD INFECTION. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT. THE CAUSE OF THE EVENT WAS REPORTED AS DUE TO RHODOTORULA MUCILAGINOSA. IT WAS REPORTED THE PATIENT INITIALLY PRESENTED TO ¿THE UNIT¿, RECEIVED TREATMENT OF INTRAPERITONEAL (IP) INJECTION OF CEFAZOLIN (1 G) AND IP CEFTAZIDIME (1 G) THEN ¿RETURNED HOME¿. THE PATIENT RETURNED TO THE UNIT TWO DAYS LATER AND TREATMENT WAS CHANGED TO IP FLUCONAZOLE (200 MG/DAY), DUE TO NO IMPROVEMENT. ON AN UNREPORTED DATE, THE FLUCONAZOLE WAS CHANGED TO INTRAVENOUS LIPOSOMAL AMPHOTERICIN B, (3 MG/KG/D). TWO DAYS LATER, IT WAS REPORTED THE PATIENT ¿IMPROVED CLINICALLY¿, AND THE PERITONEAL LIQUID WAS CLEAR AND STERILE. FOUR DAYS AFTER ¿TREATMENT¿, THE PD CATHETER WAS REMOVED AND REPLACED WITH A NEW PD CATHETER, AS IT WAS REPORTED THE PATIENT REFUSED TO TRANSFER TO HEMODIALYSIS THERAPY. THE DAY AFTER THE PD CATHETER WAS PLACED, THE PATIENT BEGAN AUTOMATED PD THERAPY ON A TIDAL PROGRAM USING SMALL VOLUMES. THE PATIENT CONTINUED WITH INTRAVENOUS ANTIFUNGAL THERAPY AT HOME FOR 4 WEEKS. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME WAS REPORTED AS RECOVERING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189513 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention EXTRANEAL