BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6063450 · Received October 28, 2016

    Report

    Report Number
    1416980-2016-16736
    Event Type
    Death
    Date Received
    October 28, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 8, 2016
    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.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY PERITONEAL DIALYSIS (PD) EFFLUENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS DIAGNOSED WITH THE PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH INJECTION VANCOMYCIN (2 GRAMS, IMMEDIATELY, STAT AND STOPPED AFTER THE FIRST DOSE, INTRAPERITONEALLY [IP]); INJECTION MEROPENEM (1 GRAM ONCE DAILY, IP), AND TOBRAMYCIN (40 MILLIGRAM ONCE DAILY, IP). DURING HOSPITALIZATION, IT WAS REPORTED THAT ¿THE PATIENT¿S HEALTH CONDITION DETERIORATED FURTHER¿ (NO FURTHER DETAIL WAS PROVIDED). FIVE DAYS AFTER BEING ADMITTED TO THE HOSPITAL, THE PATIENT¿S CONDITION BECAME CRITICAL AND AS A RESULT, ON THE SAME DATE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND DIRECTLY ADMITTED TO THE I.C.U. (INTENSIVE CARE UNIT) WHERE THE PATIENT WAS IMMEDIATELY PUT ON A VENTILATOR. EIGHT DAYS AFTER PERITONITIS ONSET, IT WAS REPORTED THAT THE PATIENT WAS NOT RECOVERING FROM THE PERITONITIS EVENT AND THEREFORE, CAPD THERAPY WAS DISCONTINUED, THE PATIENT¿S PD CATHETER WAS REMOVED, AND THE PATIENT WAS PLACED ON HEMODIALYSIS THERAPY ON THE SAME DATE. ON THE SAME DATE, THE INJECTION MEROPENEM ROUTE WAS CHANGED FROM IP TO IV (INTRAVENOUS) AND THE INITIAL DOSE AND FREQUENCY WAS CONTINUED. ON THE SAME DATE, THE INJECTION TOBRAMYCIN ROUTE WAS CHANGED FROM IP TO IV AND THE INITIAL DOSE AND FREQUENCY WAS CONTINUED. THREE DAYS LATER, THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CAUSE. THE PATIENT WAS STILL IN THE HOSPITAL, IN THE ICU AT THE TIME OF DEATH AND THE PATIENT HAD NOT RECOVERED FROM THE PERITONITIS PRIOR TO DEATH. MEROPENEM AND TOBRAMYCIN TREATMENTS WERE ONGOING UNTIL THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716481 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R DIANEAL 1.5% & 2.5% PD2 ULTRABAG