BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008T HEMODIALYSIS SYSTEM WITH CDX

    MDR report key: 4844327 · Received June 3, 2015

    Report

    Report Number
    2937457-2015-01047
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 5, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K113427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY INITIALLY REPORTED THAT THE UF PUMP WAS OUT OF CALIBRATION BY .50. THE MANUFACTURER'S CLINICAL SERVICES DEPARTMENT ADVISED THE USER FACILITY THAT THIS WOULD NOT CAUSE OR CONTRIBUTE TO THE PATIENT EVENT. THE DEVICE WAS CALIBRATED AND RETURNED TO SERVICE. 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 RECORD REVIEW: MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY POST MARKET SURVEILLANCE CLINICAL STAFF. IT WAS NOTED THAT THERE WAS NO DOCUMENTATION IN THE MEDICAL RECORDS THAT INDICATED A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S HEMODIALYSIS TREATMENT AND THE EVENTS. DEVICE REVIEW: THE USER FACILITY DID NOT REQUEST AN EVALUATION OF THE DEVICE BY THE MANUFACTURER'S REGIONAL EQUIPMENT SPECIALIST. NO PARTS WERE RETURNED FOR PRODUCT INVESTIGATION. SYSTEM LEVEL REVIEW OF THE 2008T MACHINE'S CONCOMITANT PRODUCTS FOUND THAT THERE IS NO INFORMATION AVAILABLE TO CONCLUDE THAT THE PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION DIALYSIS ORDERS (B)(6) 2015 DIALYZER 180NRE OPTIFLUX, OLV-V- 39 70, DFR- AUTOFLOW 1.5, DIALYSATE COMPOSITION 2.0K, 2.5CA, 1.0MG, 100 DEXTROSE. SODIUM (MEQ/L) 137, BFR- 450 BICARB MACHINE SETTING (MEQ/L) 35, SCHEDULED HOURS 4.0, ESTIMATED DRY WEIGHT (B)(6). BLOOD VOLUME PROCESSED- 108. ADDITIONAL INFORMATION FROM MEDICAL RECORDS: WHEN EMS ARRIVED, THE PATIENT WAS PLACED ON A MONITOR AND GIVEN EPINEPHRINE. HIS PULSE RETURNED BUT THE PATIENT WAS,NOTED TO BE IN ATRIAL FIBRILLATION. EMS ATTEMPTED AN AIRWAY BUT WAS UNSUCCESSFUL DUE TO GAGGING ON THE WAY TO THE HOSPITAL, EMS ADMINISTERED OXYGEN VIA BAG-VALVE MASK. THE PATIENT ARRIVED AT THE HOSPITAL SOMNOLENT, BUT RESPONDED WITH PAINFUL STIMULI. HE WAS HYPOXIC, WITH OXYGEN SATURATIONS IN THE 70'S AND IN ATRIAL FIBRILLATION. THE PATIENT WAS PUT ON A BIPAP AND TOLERATED IT WELL. HIS PULSE OXIMETRY IMPROVED TO 82 ON A NON-REBREATHER MASK. VITAL SIGNS UPON ARRIVAL WERE AS FOLLOWS: HEART RATE 112 (IRREGULAR), RESPIRATORY RATE 33, B/P 214/119 LABS WERE DRAWN. PATIENT WAS SEEN BY CARDIOLOGY IN THE ER AND STARTED ON INTRAVENOUS HEPARIN AND AMIODARONE. IN ADDITION, THE PATIENT WAS STARTED ON ZOSYN FOR SUSPECTED ASPIRATION PNEUMONITIS AND DIMINISHED BREATH SOUNDS IN THE RIGHT LOWER BASE. THE PATIENT WAS ADMITTED INTO THE ICU DIAGNOSED WITH CARDIAC ARREST, NON-ST SEGMENT MYOCARDIAL INFARCTION, END-STAGE RENAL DISEASE, HYPOXIA, RESPIRATORY ARREST, HYPOKALEMIA, ASPIRATION PNEUMONITIS. PATIENT HAD A CARDIAC CATHETERIZATION (B)(6) 2015 AND ANOTHER CARDIAC CATHETERIZATION WITH RIGHT CORONARY ARTERY STENTING ON (B)(6) 2015. THE PATIENT REQUIRED ADMISSION INTO THE HOSPITAL ON (B)(6) 2015 FOR PLACEMENT OF AN AICD.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMEDICAL TECHNICIAN REPORTED THAT PATIENT WAS FOUND UNRESPONSIVE DURING HEMODIALYSIS TREATMENT. FROM MEDICAL RECORDS: THE PATIENT WAS RESPONSIVE AND ALERT AT 14:50 AND HAD WHAT APPEARED TO BE A SEIZURE AND IMMEDIATELY WAS UNRESPONSIVE. CPR WAS INITIATED AT 14:50 FOR PULSELESSNESS. AED APPLIED, INITIAL SHOCK GIVEN AS DIRECTED PER AED. OXYGEN WAS ADMINISTERED AND EMS WAS CALLED. PATIENT WAS SHOCKED FOUR MORE TIMES AND CPR PER AED DIRECTIVE UNTIL EMS ARRIVED. FIVE HUNDRED CC NORMAL SALINE ADMINISTERED, PATIENT WAS DISCONNECTED FROM DIALYSIS MACHINE VENOUS PORT; REMAINED PATENT FOR EMS USE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL. THE HEMODIALYSIS CLINIC'S UNIT MANAGER REPORTED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 AND HAS RETURNED TO THE HEMODIALYSIS CLINIC. HE HAS BEEN RECEIVING HEMODIALYSIS WITH NO PROBLEMS. MEDICAL RECORDS ARE BEING REVIEWED BY POST MARKET SURVEILLANCE CLINICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360691 FRESENIUS 2008T HEMODIALYSIS SYSTEM WITH CDX KDI FRESENIUS MEDICAL CARE NORTH AMERICA T

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R NATURALYTE| FRESENIUS DIALYZER| GRANUFLO| SALINE