BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 11083860 · Received December 28, 2020

    Report

    Report Number
    1416980-2020-08095
    Event Type
    Death
    Date Received
    December 28, 2020
    Report Date
    December 28, 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 PERITONITIS EVENT. THE PATIENT WAS TREATED WITH INJECTION OF MEROPENEM 1GM AND INJECTION OF VANCOMYCIN 1GM (NO FURTHER DETAILS). IT WAS REPORTED THAT A PATIENT PASSED AWAY (DURING HOSPITALIZATION). THE CAUSE OF DEATH WAS REPORTED AS DUE TO CARDIAC ARREST. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE PATIENT WAS NOT RECOVERING FROM THE PERITONITIS EVENT AT THE TIME OF DEATH. IT WAS REPORTED ANTIBIOTIC AND PD THERAPY WERE ONGOING PRIOR TO AND AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549411 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H| R DIANEAL 2.5% PD2| EXTRANEAL 7.5% PD2