BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 100 UF 500

    MDR report key: 499178 · Received November 25, 2003

    Report

    Report Number
    85072-2003-00001
    Event Type
    Injury
    Date Received
    November 25, 2003
    Date of Event
    November 13, 2003
    Report Date
    November 20, 2003
    Manufacturer
    CHF SOLUTIONS, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO MEDICAL CENTER, IN 2003 FOR FLUID OVERLOAD. APPROXIMATELY 6 WEEKS PRIOR TO ADMISSION, PATIENT WAS TREATED AT HOSPITAL IN BY THE SAME PHYSICIAN FOR THE SAME CONDITION. AT HOSPITAL, THE PATIENT WAS TREATED WITH THE SYSTEM 100 ULTRAFILTRATION DEVICE AND HAD A SUCCESSFUL TREATMENT WITHOUT ANY ADVERSE EFFECTS. THE NEXT DAY THE PATIENT HAD CHF SOLUTIONS MODEL 1535 EXTENDED LENGTH CATHETER (ELC) PLACED IN THE RIGHT ANTECUBITAL VEIN BY THE ATTENDING PHYSICIAN. TWO IV INFUSION CATHETERS WERE PLACED IN LEFT ARM. THE SYSTEM 100 WAS PRIMED AT THE NURSE'S STATION WITH THE STANDARD PRIMING SOLUTION OF 500CC OF NORMAL SALINE AND 20,000 UNITS OF HEPARIN. AFTER THE SYSTEM 100 WAS PRIMED, THE ULTRAFILTRATION (UF) CIRCUIT TUBING WAS CONNECTED TO THE PATIENT AND THE REMAINING PRIMING SOLUTION (APPROXIMATELY 30 CC) WAS INFUSED INTO THE PATIENT. THE PATIENT WAS ALSO STARTED ON A HEPARIN SALINE DRIP. AS THE BLOOD FROM THE WITHDRAWAL LINE (ELC) WAS BEING PUMPED TO THE UF FILTER, THE PATIENT COMPLAINED THAT THEY FELT HOT TURNED BEET RED AND WENT INTO RESPIRATORY ARREST AND BECAME NON-RESPONSIVE. BLOOD PRESSURE DROPPED FROM 110 TO 70 SYSTOLIC. EKG SHOWED 100% PACED WITH ATRIAL FIBRILLATION. A FACE MASK WITH 100% OXYGEN AND POSITIVE PRESSURE VENTILATION WAS BEGUN. 0.5 MG OF EPINEPHRINE AND 2MG/KG OF DOPAMINE WERE GIVEN AND PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT (CCU). IN THE CCU THE PATIENT BECAME RESPONSIVE TO FAMILY. THIRTY MINUTES AFTER BEING ADMITTED TO THE CCU, ULTRAFILTRATION THERAPY WITH THE SYSTEM 100 WAS RESTARTED AFTER THE ORIGINAL CIRCUIT WAS DISCARDED AND A NEW CIRCUIT INSTALLED. DURING THE FIRST TWO HOURS THE PATIENT COMPLAINED OF BEING COLD AND HAD A TEMPERATURE OF 96 F. IN SPITE OF INCREASING THE TEMPERATURE IN THE ROOM AND EXTRA BLANKETS, THE PATIENT STILL COMPLAINED OF BEING COLD AND HAD UNCONTROLLED SHIVERING. APPROXIMATELY TWO HOURS AFTER THE START OF THE TREATMENT, THE PATIENT VOMITED LIQUID WITH ORANGE COLORED BITS IN THE VOMIT. THE PATIENT WAS GIVEN 25 MG OF DEMEROL, BENADRYL (ANTIHISTAMINE) AND SOLUMEDROL (STEROID). THE PATIENT WENT TO SLEEP AND UF TREATMENT WAS COMPLETED AT 5 HOURS AND 40 MINUTES LATER FOR A TOTAL FILTRATION TIME OF 7 HOURS AND 40 MINUTES. APPROXIMATELY 2 HOURS AFTER THE COMPLETION OF ULTRAFILTRATION TREATMENT, BLOOD PRESSURE DROPPED TO 78/43 MMHG AND 2 MG/KG OF DOPAMINE WAS ADMINISTERED. BLOOD PRESSURE INCREASED TO 104/45. THEY HAD NO FURTHER HYPOTENSIVE EPISODES. DURING THE INITIAL EPISODE TWO BLOOD CULTURES WERE TAKEN AT 35 AND 40 MINUTES. THE FIRST CULTURE YIELDED STAPH. AUREUS AND ALPHA HEMOLYTIC STREP. THE SECOND CULTURE YIELDED ALPHA HEMOLYTIC STREP ONLY. SERIAL CHEST X-RAYS SHOWED NO SIGNIFICANT DIFFERENCES. THE PATIENT'S BLOOD WORK SHOWED A SIGNIFICANT ELEVATION IN WBC WITH AN INCREASE IN NEUTROPHILS AND A DECREASE IN LYMPHOCYTES WITH A SLIGHT RISE IN THROMBOCYTE. WHITE COUNT RETURNED TO PRE TREATMENT THE FOLLOWING DAY. AT LAST REPORT THE PATIENT HAD NOT EXPERIENCED ANY FURTHER EPISODES OF HYPOTENSION OR OTHER ADVERSE EVENTS. THEY WERE ABLE TO BE RELEASED FROM THE HOSPITAL ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 100 UF 500 DIALYZER, HIGH PERMEABILITY KDI CHF SOLUTIONS, INC. A1550 3061

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R MODEL AND CATALOG#: A1535, LOT #3089,| EXPIRATION DATE 2005/08, EXTENDED LENGTH CATHETER| (ELC)