BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 9721458 · Received February 18, 2020

    Report

    Report Number
    1416980-2020-00769
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    July 13, 2016
    Report Date
    February 18, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: HABE, T., FUTAMURA, A., FURUTANI, M., HONDA, M. ¿INFECTION/EPS: A CASE OF PERITONEAL DIALYSIS-RELATED PERITONITIS WITH DIFFICULTY IN DISTINGUISHING FROM ENCAPSULATION PERITONEAL SCLEROSIS¿. PERITONEAL DIALYSIS (2019): 221-223. 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 PERITONITIS WHICH WAS MANIFESTED BY PYREXIA, EPIGASTRIC PAIN AND CLOUDY EFFLUENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. A DAY AFTER THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN, CEFOPERAZONE/SULBACTAM FOR FIVE DAYS. WITH SYMPTOMS WORSENING, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE PATIENT WAS TREATED WITH MEROPENEM, VANCOMYCIN AND MICAFUNGIN (DOSES, ROUTES, FREQUENCIES AND DURATIONS NOT REPORTED) FOR APPROXIMATELY ONE MONTH. ABDOMINAL PAIN AND BLOATING PERSISTED AND PARALYTIC ILEUS WAS DIAGNOSED. AN ILEUS TUBE WAS PLACED ON DAY TWENTY ONE AND WAS LATER REMOVED AFTER APPROXIMATELY ONE MONTH OF PLACEMENT. SEVENTY THREE DAYS INTO THE EVENT, THE PATIENT BEGAN TREATMENT WITH ISONIAZID, RIFAMPICIN AND ETHAMBUTOL (DOSES, ROUTES, FREQUENCIES AND DURATION NOT REPORTED) FOR THE EVENT. AFTER THREE WEEKS, ANTIBIOTIC TREATMENT WAS DISCONTINUED. ON DAY ONE HUNDRED AND TWENTY FIVE, THE PATIENT BEGAN TREATMENT WITH PREDNISOLONE (20 MG, ROUTE, FREQUENCY AND DURATION NOT REPORTED) FOR THE EVENT. IT WAS REPORTED THAT RAPID IMPROVEMENT WAS OBSERVED AND ON DAY ONE HUNDRED AND THIRTY TWO, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PREDNISOLONE TREATMENT WAS TAPERED DOWN AND AFTER APPROXIMATELY SIX MONTHS, TREATMENT WITH PREDNISOLONE WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185408 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R