BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 10622032 · Received October 2, 2020

    Report

    Report Number
    1416980-2020-06150
    Event Type
    Death
    Date Received
    October 2, 2020
    Date of Event
    July 16, 2020
    Report Date
    October 2, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TWO DAYS AFTER EVENT ONSET, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) INJECTION OF VANLID (1 GM STAT) AND IP INJECTION OF CEFTAZIDIME (1 GM DAILY, DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION OF VANCOMYCIN (1 GM, FREQUENCY AND DURATION NOT REPORTED) AND INJECTION OF MEROPENEM (500 MG, FREQUENCY AND DURATION NOT REPORTED) FOR THE PERITONITIS. ON AN UNKNOWN DATE DURING HOSPITALIZATION, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. AT THE TIME OF DEATH, THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. ON AN UNKNOWN DATE PRIOR TO DEATH, PD THERAPY WAS DISCONTINUED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083767 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| R COVIDIEN PD CATHETER| DIANEAL PD2 2.5%| EXTRANEAL