BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10390718 · Received August 11, 2020

    Report

    Report Number
    1416980-2020-04885
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 3, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION; B2, B3, B5, B6, B7 AND H6. B5: THE PATIENT WAS DIAGNOSED OF BACTERIAL PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FIVE DAYS AFTER ONSET AND WAS TREATED WITH CEFTAZIDIME (1 GR, INTRAPERITONEALLY (IP)/DAILY DURING THE FIRST DAY AND LATER 1812.5 MG/DAILY IP AND VANCOMYCIN 1 GR IP/DAILY DURING THE FIRST DAY AND LATER 217 MG/DAILY IP BOTH TREATMENTS FOR FIVE DAYS CATHETER WAS WITHDRAWN AND THE PATIENT WAS STARTED ON HEMODIALYSIS (HD)). THE PATIENT WAS TREATED WITH GENTAMYCIN 8(0MG/48 HOURS) AND VANCOMYCIN (500MG/48 HOURS) BOTH AFTER HD TREATMENT, FOR TWENTY- EIGHT DAYS. THE PATIENT WAS ALSO TREATED WITH FLUCONAZOLE (100MG ORALLY). FIFTEEN DAYS AFTER HOSPITALIZATION, THE PATIENT WAS DISCHARGED AND IS RECOVERING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 CLOUDY EFFLUENT. THE CAUSE WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854635 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R NUTRINEAL| NUTRINEAL