BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP

    MDR report key: 2881657 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07783
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER GD892984 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS WERE NOTED.THE REPORTED PROBLEMS WERE NOT CONFIRMED AND THE CAUSE OF THE EVENTS COULD NOT BE DETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT FROM A NURSE WITH SUPPLEMENTAL INFORMATION PROVIDED BY A DOCTOR IN THE USA OF SEPSIS, PERITONITIS, AND DEATH COINCIDENT WITH DIANEAL THERAPY. DIANEAL THERAPY IS ONGOING UNTIL THE TIME OF DEATH. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT DIED DUE TO COMPLICATIONS FROM PERITONITIS. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. THE NURSE COULD NOT CONFIRM THE CAUSE OF DEATH BUT STATED THE DEATH WAS UNRELATED TO PERITONEAL DIALYSIS (PD) THERAPY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012. THE NURSE COULD NOT CONFIRM THE CAUSE OF DEATH AS COMPLICATIONS FROM PERITONITIS. THE NURSE STATED THE PATIENT'S SPOUSE HAD REPORTED THAT THE PATIENT'S PERITONEAL FLUID WAS CLEAR BUT THE NURSE COULD NOT CONFIRM. FURTHER INFORMATION WAS RECEIVED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT HAD BEEN ON PD THERAPY FOR 4 YEARS AND HAD RECURRENT PERITONITIS ANNUALLY. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR SEPSIS MANIFESTED BY VOMITING AND PERITONITIS (DIAGNOSED AS PERITONITIS DUE TO CITROBACTER) MANIFESTED BY ABDOMINAL PAIN (ONSET DATES NOT REPORTED). THE PATIENT WAS TREATED WITH ANCEF AND CEFTAZIDIME (DOSES AND FREQUENCIES NOT REPORTED) INTRA-PERITONEALLY (IP) FOR THE PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DESPITE BEING TREATED WITH BROAD SPECTRUM ANTIBIOTICS, THE PATIENT CONTINUED TO WORSEN AND WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 FOR RECURRENT PERITONITIS MANIFESTED BY SHARP ABDOMINAL PAIN AND CLOUDY PERITONEAL DIALYSATE (DATES NOT REPORTED). THE PATIENT WAS TREATED FOR RECURRENT PERITONITIS WITH ERTAPENEM (ROUTE, DOSE, AND FREQUENCY NOT REPORTED) WHICH WAS CONTINUED THROUGH (B)(6) 2012. DURING THE HOSPITALIZATION, THE PATIENT EXHIBITED STRANGE BEHAVIOR AND WAS CONFUSED AT TIMES WITH SOME TWITCHING MOVEMENTS. THE PATIENT ALSO HAD OBSTRUCTIVE SLEEP APNEA, MANIFESTED BY DEEP SLEEP, SNORING LOUDLY, APNEIC MOVEMENTS, AND DOCUMENTED DE-SATURATIONS INTO THE 70'S (DATES NOT REPORTED). THE PATIENT WAS ADVISED TO WEAR A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) BUT HE REFUSED TO WEAR IT. ARTERIAL BLOOD GAS (ABG) WAS CHECKED AND THE OXYGEN PARTIAL PRESSURE (PO2) WAS 40%. ON (B)(6) 2012, THE PATIENT WAS AGITATED, DURING AN ATTEMPT TO REPOSITION HIM, BUT THE PATIENT WAS UNRESPONSIVE. ON THAT SAME DAY, THE PATIENT WAS BRADYCARDIAC IN THE 50'S AND HIS BLOOD PRESSURE WAS UNABLE TO BE OBTAINED. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). ON (B)(6) 2012, THE PATIENT EXPERIENCED ACUTE CARDIOPULMONARY ARREST AND DIED IN THE ICU DUE TO ACUTE CARDIOPULMONARY ARREST, ACUTE HYPOXEMIC RESPIRATORY FAILURE, OBSTRUCTIVE SLEEP APNEA, ESRD DUE TO UNCONTROLLED HYPERTENSION, RECURRENT PERITONITIS, LATENT TUBERCULOSIS WITH POSITIVE QUANTIFERON TEST, HYPERLIPIDEMIA, HEMORRHOIDS, ESOPHAGITIS, FATAL HYPERPARATHYROIDISM, CORONARY ARTERY DISEASE, AND DILATED ASCENDING AORTIC ARCH (ONSET DATES NOT REPORTED). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| R UNKNOWN DIANEAL