BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3354128 · Received September 16, 2013

    Report

    Report Number
    2937457-2013-00189
    Event Type
    Death
    Date Received
    September 16, 2013
    Date of Event
    April 22, 2010
    Report Date
    August 19, 2013
    Manufacturer
    FRESENIUS USA, INC
    Product Code
    KDI
    PMA / PMN Number
    994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY THE POST MARKET CLINICAL STAFF AND PHYSICIAN. THE PT IS A (B)(6) YEAR OLD MALE DIALYSIS PT, WITH HISTORY OF END-STAGE KIDNEY DISEASE, MELLITUS DIABETES, HYPERTENSION, RENAL FAILURE, AND CABG. PT HAD A RENAL TRANSPLANT POSSIBLY IN 2009 AND STARTED HEMODIALYSIS IN (B)(6) 2008. THE LATEST LABS ON RECORD OF (B)(6) 2010, INDICATED BICARB OF 24 AND K 3.9 TO BE WITHIN NORMAL VALUE LEVELS. BASED ON THE INFO RECEIVED, PT'S MEDICAL HISTORY, HOSPITAL RECORDS AND CERTIFICATE OF DEATH; THE PT HAD SEVERAL COMORBIDITIES CONTRIBUTING TO HIS DEMISE. PT WITH A FAILED KIDNEY TRANSPLANT, INITIATED ON HEMODIALYSIS FOR RENAL REPLACEMENT THERAPY, WAS FOUND UNCONSCIOUS AND IN VENTRICULAR FIBRILLATION DURING HIS TREATMENT ON DIALYSIS. THE LEADING CAUSE OF V FIB IS CARDIAC DISEASE. AT THIS POINT, THERE IS NO INDICATION OF ANYTHING UNUSUAL DURING THE HEMODIALYSIS TREATMENT PRIOR TO THIS EVENT; THERE IS NO HISTORY OF DEVICE MALFUNCTION OR PRODUCTS OUT OF SPECIFICATION. UPON ARRIVAL, PT RECEIVED BICARBONATE, WHICH IS THE STANDARD MEDICAL PROCEDURE TO THE ACIDOSIS IN PT ON DIALYSIS AND/OR IN CARDIOPULMONARY ARREST. THE CERTIFICATE OF DEATH INDICATED CAUSE OF DEATH WAS CORONARY ATHEROSCLEROSIS WITH DIABETES MELLITUS AS THE SIGNIFICANT CONTRIBUTING CONDITION. PRODUCT IDENTIFIERS WERE NOT PROVIDED FOR EVAL. A HISTORICAL RECORD REVIEW OF THE PRODUCTION LOTS IDENTIFIED THROUGH THE TREATMENT RECORD REVIEW HAS BEEN REQUESTED, HOWEVER, HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS ONE EVENT REPORTED ON THE SAME PT INVOLVING SIX SEPARATE PRODUCTS AND ASSOCIATED WITH MDRS #: 2937457-2013-00189, 1225714-2013-01048, 1225714-2013-01049, 8030665-2013-00595, 1713747-2013-00427, 1713747-2013-99944.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE (HEMODIALYSIS MACHINE, MODEL 2008K) IS UNAVAILABLE FOR AN INVESTIGATION. THE SERIAL NUMBER WAS NOT PROVIDED/AVAILABLE THEREFORE, THE DEVICE HISTORY RECORDS (DHR) ON THE HEMODIALYSIS MACHINE COULD NOT BE PERFORMED. ALL DHR ARE REVIEWED AND RELEASED ACCORDING TO DHR REVIEW CHECKLIST AND RELEASE PROCEDURE; A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, A DHR REVIEW WAS PERFORMED ON ALL FRESENIUS DISPOSABLE PRODUCTS THT WERE POTENTIALLY IN USE AT THE TIME OF THE REPORTED EVENT. ALTHOUGH, LOT NUMBERS WERE NOT CONFIRMED OR PROVIDED; THE PRODUCT LOTS WERE IDENTIFIED UTILIZING SALES AND SHIPMENT HISTORY. NO NON-CONFORMANCES WERE IDENTIFIED AND ALL IDENTIFIED LOTS MET SPEC PRIOR TO DISTRIBUTION. MULTIPLE F/U ATTEMPTS TO OBTAIN PRODUCT IDENTIFIERS WERE UNSUCCESSFUL. THE SYSTEM LEVEL REVIEW OF THE 2008K DEVICE AND CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED IN ANY WAY TO THE CLINICAL EVENT.

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE EVENT FOR THE SAME PT INVOLVING SIX SEPARATE PRODUCTS; ASSOCIATED MDR NUMBERS: 2937457-2013-00189, 1225714-2013-01048, 01049, 8030665-2013-00595, 1713747-2013-00427, 99944.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY. IT WAS REPORTED THE DECEDENT WAS IN DIALYSIS ON (B)(6) 2010 AND APPROX 1 HOUR INTO DIALYSIS TREATMENT, THE DECEDENT ARRESTED AND PASSED OUT. CPR WAS ADMINISTERED. CARDIAC RHYTHM WAS IN VENTRICULAR FIBRILLATION. DECEDENT WAS TAKEN TO THE HOSPITAL AND PRONOUNCED DEAD AT 8:40 A.M. ON (B)(6) 2010: ON EMERGENCY MEDICINE FOR RENAL FAILURE AND DEHYDRATION. ON (B)(6) 2010: PT WAS TRANSFERRED TO THE HOSPITAL WITH SYMPTOMS OF RENAL FAILURE AND POSSIBLY ALLOGRAFT KIDNEY REJECTION. PT IS PRESENTING WITH LIKELY KIDNEY REJECTION SECONDARY TO NOT TAKING IMMUNOSUPPRESSIVE. DISCHARGED (B)(6) 2010. VITAL SIGNS RECORDED PRE/POST DIALYSIS TREATMENT, BP SIT: PRE 108/47-POST 95/68, BP STD PRE: 98/47-POST 0/0. PULSE PRE: 75-POST 112, TEMP: PRE 97.6-POST 0.0. HD TREATMENT FLOW-SHEET DATE: (B)(6) 2010; FORMULA:2K 2.25 CA BICARB 38. ACCESS TYPE: AV FISTULA (RIGHT BRACHIAL ARTERY) CERTIFICATE OF DEATH REVEALED EXTENSIVE MYOCARDIAL FIBROSIS. CONSISTENT WITH REMOTE MYOCARDIAL INFARCT VARIABLE HYPERTROPHY OR MYOSITIS, CALCIFIC CORONARY ATHEROSCLEROSIS. THE CAUSE OF DEATH WAS CORONARY ATHEROSCLEROSIS AND DIABETES MELLITUS AS THE SIGNIFICANT CONTRIBUTING CONDITION.

    Description of Event or Problem · 1

    THE ADD'L INFO ALLEGES THE PT ARRESTED DUE TO ALKALOSIS OR ELEVATED BICARBONATE LEVELS. AUTOMATIC EXTERNAL DEFIBRILLATOR WAS ADMINISTERED AND SHOCK WAS GIVEN. PT HAD NO PULSE FOR AT LEAST 12 MINUTES BEFORE HE ARRIVED AT THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464711 FRESENIUS 2008K KDI FRESENIUS USA, INC 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death