BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS OPTIFLUX F 180 NRE

    MDR report key: 3280844 · Received August 7, 2013

    Report

    Report Number
    1713747-2013-00295
    Event Type
    Death
    Date Received
    August 7, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 15, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNRESPONSIVENESS. IT WAS REPORTED THAT THE PT EXPERIENCED AN ADVERSE EVENT DURING TREATMENT WITH FRESENIUS PRODUCTS. A SYSTEM LEVEL REVIEW IS BEING CONDUCTED FOR ALL CONCOMITANT PRODUCTS IN USE DURING THE TREATMENT. IT IS CURRENTLY UNK IF THE PT'S UNRESPONSIVENESS AND SUBSEQUENT EXPIRATION ARE RELATED TO THE REPORTED EVENT. THE PT HAS SEVERAL CO-MORBIDITIES INCLUDING BUT NOT LIMITED TO, END STAGE RENAL DISEASE SECONDARY TO DIABETES MELLITUS, DIABETES MELLITUS FOR 30 YEARS, HYPERTENSION, CORONARY ARTERY DISEASE WITH HISTORY OF CORONARY ANGIOPLASTY, HISTORY OF EJECTION FRACTION OF 63%, MALIGNANT HYPERTENSION BRADYCARDIC ARREST X2, JUNCTIONAL TACHYCARDIC EVENT, ACUTE AND POTENTIALLY CHRONIC HYPOXIC RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE, OLD MYOCARDIAL INFARCTION, POLYNEUROPATHY AND THE PT WAS OXYGEN DEPENDENT. THE NIGHT BEFORE THE EVENT THE PT STAYED WITHOUT OXYGEN FOR 7 HOURS. THE MEDICAL RECORDS PROVIDED AND REVIEWED BY THE POST MARKET CLINICAL STAFF AND PHYSICIAN. A DEATH CERTIFICATE AND AUTOPSY REPORT WERE REQUESTED BUT HAVE NOT BEEN RECEIVED TO DATE. WITHOUT THE DEATH CERTIFICATE AND AUTOPSY REPORT, IT IS UNKNOWABLE WHETHER ANY OF THE PT'S MANY COMORBIDITIES CAUSED THE PT'S DEMISE. THE PLANT INVESTIGATION IS CURRENTLY ONGOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED AT THE CONCLUSION. THIS IS ONE OF 5 MDRS SUBMITTED TO DOCUMENT THIS REPORT EVENT. PLEASE REFERENCE THE FOLLOWING MDR NUMBERS: 2937457-2013-00130, 1713747-2013-00295, 8030665-2013-00505, 1225714-2013-02228, 1713747-2013-99923.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A REGIONAL EQUIPMENT SPECIALIST, THAT A REQUEST WAS MADE FOR A MACHINE INSPECTION, POST ADVERSE EVENT WHERE PATIENT EXPIRED WHILE ON THE HEMODIALYSIS MACHINE. DURING A FOLLOW-UP CALL WITH THE PT'S RN SHE STATED THAT ON (B)(6) 2013, THE PT CAME TO DIALYSIS FOR HIS REGULAR TREATMENT. PRE-TREATMENT ASSESSMENT SHOWED THAT THE PATIENT HAD O2 BACK ON, STABLE, TALKATIVE, VITAL SIGNS WITHIN NORMAL LIMITS. PRE-TX BP: 151/83 HR: 87. BP AT START OF TX: 132/72 HR: 87. AT 8 MINUTES AFTER THE START OF THE TREATMENT, THE PT STARTED HAVING SEIZURE ACTIVITY, HAD AGONAL BREATHING AND BECAME UNRESPONSIVE. A CODE WAS CALLED AND THE PATIENT WAS GIVEN 3,000 ML OF FLUID. CPR WAS PERFORMED, AED WAS INITIATED BUT A SHOCK WAS NOT ADVISED. EMS SERVICES WERE INITIATED AND THEY ARRIVED AFTER 30 MINUTES INTO THE CODE. THE PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE EXPIRED ON THE SAME DAY, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371921 FRESENIUS OPTIFLUX F 180 NRE FJI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| L FRESENIUS COLLECTIVE CONCENTRATE - NATURALYTE| FRESENIUS COMBISET| FRESENIUS 2008 KW HEMODIALYSIS MACHINE| FRESENIUS DIALYZER| FRESENIUS NORMAL SALINE