BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI SET 8MM PRE 2 VENOUS INJECT SITES

    MDR report key: 5104313 · Received September 24, 2015

    Report

    Report Number
    8030665-2015-00442
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS BUT HAS NOT YET RECEIVED THEM. THE PLANT INVESTIGATION IS IN PROGRESS. THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE RECEIVED. THE RESULTS OF THE CLINICAL INVESTIGATION ARE AS FOLLOWS: THE PT CODED AFTER ULTRAFILTRATION WAS TURNED ON THE HEPARIN BOLUS ADMINISTERED. ACCORDING TO THE PT'S DEATH CERTIFICATE, THE PT'S CAUSE OF DEATH WAS LETHAL ARRHYTHMIA, DUE TO ACUTE MYOCARDIAL INFARCTION, CORONARY ATHEROSCLEROSIS AND CHRONIC RENAL FAILURE. NO AUTOPSY REPORT WAS PERFORMED. MEDICAL RECORDS REVEAL THAT THE PT BECAME UNRESPONSIVE REQUIRING CPR DURING A DIALYSIS TREATMENT ON (B)(6) 2015 AS WELL. THE PT IN ALL CASES RECOGNIZED THAT AN ADVERSE EVENT WAS OCCURRING. THERE IS NO INDICATION THAT THE PHYSICIAN INTENDED TO CHANGE DIALYSIS PRODUCTS AFTER THE (B)(6) 2015 EVENTS. PT ALSO HAD A HISTORY OF ATRIAL FIBRILLATION AS WELL AS OTHER CARDIAC ISSUES. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES THE PT HAD ANY ADVERSE REACTION TO THE DIALYSATE OR OTHER PRODUCT ASSOCIATED WITH THE DIALYSIS. THERE WAS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES THERE WAS A CAUSAL RELATIONSHIP BETWEEN PT'S HEMODIALYSIS TREATMENT AND CONCOMITANT PRODUCTS AND THE PT'S DEATH. THE (B)(6) 2015 EVENTS FOUND DURING MEDICAL RECORD REVIEW HAVE BEEN REPORTED SEPARATELY. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL. THE CUSTOMER WAS UNABLE TO PROVIDE THE MFR WITH THE LOT NUMBER OF THE DIALYZER USED IN THE REPORTED EVENT. AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH OF THE LOT NUMBERS SHIPPED TO THE COMPLAINANT IN THE THREE MONTH LEADING UP TO THE REPORTED EVENT. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED. THE BATCH RECORDS CONFIRMED THAT RELEASED PRODUCT MET SPECS; AND DOCUMENTED MFG PROCESS CONTROLS WERE WITHIN SPEC. PER THE DOCUMENTED PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS DIALYZER CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT.

    Description of Event or Problem · 1

    A FACILITY BIOMEDICAL TECHNICIAN (BMT) TELEPHONED TECHNICAL SUPPORT TO REPORT A PT HAD PASSED AWAY DURING HIS HEMODIALYSIS TREATMENT. ACCORDING TO THE BMT, THE PT HAD DIFFICULTY BREATHING APPROXIMATELY 11 MINUTES INTO HIS TREATMENT. THE PT'S BLOOD WAS RETURNED AT THAT TIME AND HE IS REPORTED TO HAVE "CODED". HE RECEIVED CPR AND PASSED AWAY. HE WAS NOT TRANSPORTED TO THE HOSPITAL. DURING FOLLOW UP WITH THE BMT IT WAS LEARNED THE PT WAS A RESIDENT OF A NURSING HOME AND HAD A HISTORY OF CARDIAC DISEASE. THE BMT REPORTED "HIS BP WAS FINE" WHEN HE WENT INTO CARDIAC ARREST. THE EVENT OCCURRED 11 MINUTES INTO TREATMENT AND THE MACHINE WAS SET FOR ZERO FLUID REMOVAL IN THE FIRST 30 MINUTES OF TREATMENT DUE TO, ACCORDING TO THE BMT, THE PT'S SENSITIVITY TO RATE OF FLUID REMOVAL. NO PRODUCT/DEVICE MALFUNCTION IS ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE MACHINE WAS REMOVED FROM SERVICE IMMEDIATELY AFTER THE EVENT AND WAS EVALUATED BY A FRESENIUS RES. THE MACHINE WAS FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. A DIALYSATE CULTURE WAS SENT FOR EVAL. NO UNUSUAL FINDINGS WERE REPORTED. THE DIALYZER, LINES, NORMAL SALINE SOLUTION, AND CONCENTRATES IN USE HAVE BEEN DISCARDED. THE MACHINE IS BACK IN SERVICE WITHOUT ISSUE. FOLLOW UP WAS PERFORMED WITH THE FACILITY'S NURSE MANAGER (NM) WHO CONFIRMED INFO REPORTED BY THE BMT BUT CLARIFIED THE PT WAS TO HAVE REMOVED 3.5L OF FLUID DURING HIS TREATMENT BUT TOTAL FLUID REMOVAL AT THE TIME OF EVENT WAS REPORTED AS "131ML". SHE ADDED THAT THE PT WAS HIS USUAL SELF PRIOR TO TREATMENT BUT HAD REFUSED TO USE OXYGEN THAT DAY. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    DIALYSIS ORDERS: FRESENIUS OPTIFLUX 250NR. BATH 1/DUR 1: 2K25C/255, 2K, 2.5CA. BLOOD FLOW RATE: 400. DIALYSATE FLOW RATE: 800. LITERS PROCESSED: 102. TOTAL LITERS PROCESSED 78.7. FROM MEDICAL RECORDS: THE PT ARRIVED FOR TREATMENT IN A WHEELCHAIR AT 15:20. HE WAS ALERT AND ORIENTED X 3. THE PT WAS UNABLE TO STAND AT THE SCALE STATING HIS RIGHT KNEE FELT VERY WEAK. PRE-TREATMENT VITAL SIGNS: TEMPERATURE 98.7, PULSE 96/REGULAR. BLOOD PRESSURE 145/75. OXYGEN SATURATION 95% ON ROOM AIR. THE PT REFUSED OXYGEN AT THAT TIME AND CONTINUED TO REFUSE AFTER ENCOURAGEMENT FROM REGISTERED NURSE (RN). BLOOD PRESSURE UPON TREATMENT INITIATION AT 15:31 WAS 119/69, PULSE 92. ULTRAFILTRATION GOAL WAS 3.5L, AND THE ULTRAFILTRATION WAS NOT INITIATED FOR THE FIRST 15 MINS OF THE TREATMENT AS WAS THE USUAL PRACTICE. BLOOD FLOW RATE SET AT 200 ML/MIN. AT 15:42 THE PT VERBALIZED "SOMETHINGS HAPPENING", I DON'T FEEL WELL." THE PT'S BLOOD WAS RETURNED. HE WAS PULSELESS WITHOUT RESPIRATIONS. A NON-REBREATHER MASK WAS APPLIED WITH OXYGEN 10L/MIN. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND THE AUTOMATED EXTERNAL DEFIBRILLATOR WAS APPLIED. SHOCK WAS NOT ADVISED. EMERGENCY MEDICAL SERVICES WAS CALLED. THE MEDICAL DIRECTOR WAS PRESENT AND ORDERED EPINEPHRINE ADMINISTERED. PT REMAINED IN ASYSTOLE DESPITE CONTINUED CPR. CPR WAS TERMINATED PER PHYSICIANS ORDER AT 16:03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632727 COMBI SET 8MM PRE 2 VENOUS INJECT SITES FJK FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death