BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLOODLINES COMBISET

    MDR report key: 3249623 · Received July 24, 2013

    Report

    Report Number
    8030665-2013-00474
    Event Type
    Death
    Date Received
    July 24, 2013
    Date of Event
    May 25, 2011
    Report Date
    June 25, 2013
    Manufacturer
    FRESENUIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KOC
    PMA / PMN Number
    043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM LEVEL INVESTIGATION IS BEING PERFORMED TO INCLUDE THE ALL CONCOMITANT FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. AT THIS TIME, THE RESULTS HAVE NOT BEEN REC'D. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY THE POST MARKET CLINICAL STAFF AND PHYSICIAN. ACCORDING TO THE MEDICAL RECORDS ((B)(6)) PROVIDED BY THE PLAINTIFF ATTORNEY; THE PT HAD BEEN SUFFERING WITH DIARRHEA ON THE WEEKS PRIOR TO THE EVENT. DIARRHEA IS ASSOCIATED WITH A LOSS OF BICARBONATE. LABORATORY RESULTS NEAR THE DAY OF THIS EVENT ARE NOT AVAILABLE, BUT IS VERY LIKELY THAT PT HAS A METABOLIC ACIDOSIS DUE TO DEFECTS WHICH COULD HAVE CAUSED OR CONTRIBUTED TO HIS HYPOTENSION IN THE DIALYSIS UNIT. A LETHAL ARRHYTHMIA WITHOUT ACTUAL CARDIAC MONITORING IS A DIAGNOSIS OF EXCLUSION. NO RECENT BICARBONATE LEVELS WERE PROVIDED. THERE IS NO EVIDENCE THAT GRANUFLO AND NATURALYTE WAS DEFECTIVE OR MALFUNCTIONED AT THIS TIME OF THIS EVENT. ADDITIONALLY, THE CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS LISTED AS LETHAL ARRHYTHMIA, DIABETES MELLITUS 2, END STAGE RENAL DISEASE AND HYPERTENSION. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF/WHEN ADD'L INFO BECOMES AVAILABLE. PLEASE REFERENCE MDR REPORT NUMBERS: 1225714-2013-01085, 1225714-2013-01084, 2937457-2013-00102, 1713747-2013-99917, 8030665-2013-00474, AND 1713747-2013-00474.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2010 - INITIAL START OF DIALYSIS. (B)(6) 2010 - (B)(6) 2011 - MULTIDISCIPLINARY PROGRESS NOTES INDICATE PT NON-COMPLIANT WITH TREATMENT AND RE-CHECKS. ON (B)(6) 2011 - HD TREATMENT SHEET. TREATMENT ENDED 35 MINUTES EARLY DUE TO PT REQUEST SAYS HAVING ABDOMINAL CRAMPS DUE TO DIARRHEA. PT STATES LOOSE STOOLS X 2 WEEKS, AFEBRILE. PT TOOK OTC IMODIUM. RECENT SERUM K 4.9, PT ON 2K BATH. ON (B)(6) 2011 - LOW DIASTOLIC BLOOD PRESSURE DURING TREATMENT, PT BECAME UNRESPONSIVE, CPR INITIATED, AED ACTIVATED AND EMS TRANSPORTED TO HOSPITAL. PT SUBSEQUENTLY EXPIRED AT 2231. DEATH CERTIFICATE PROVIDED: PT EXPIRED ON (B)(6) 2011. CAUSE OF DEATH: LETHAL ARRYTHMIA, DIABETES MELITUS 2, END STAGE RENAL DISEASE, AND HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345126 BLOODLINES COMBISET NONE KOC FRESENUIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death DIALYZER: FRES OPTIFLUX 180NR| MACHINE: FRES 2008K| FRESENIUS SALINE