BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRLIFEHMEF 750/S, DISPOSABLE

    MDR report key: 10766884 · Received October 30, 2020

    Report

    Report Number
    3004050971-2020-00009
    Event Type
    Death
    Date Received
    October 30, 2020
    Date of Event
    October 5, 2020
    Report Date
    October 6, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CAH
    UDI-DI
    10885403284151
    PMA / PMN Number
    K031653
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NO ABNORMALITIES WERE DISCOVERED. SMALL PERCENTAGE OF THIS LOT WAS SCRAPPED DUE TO VISUAL DEFECTS AND SMALL PERCENTAGE WAS ALSO REWORKED DUE TO DEFECTS. THESE ARE NORMAL PROCEDURES. ALL HMEF PRODUCTS IN VINCENT MEDICAL PRODUCTION GO THROUGH 100% LEAK AND FLOW RESISTANCE TESTING. ADDITIONALLY, RETENTION SAMPLES FROM LOT# 0207321 WERE TESTED FOR LEAK AND FLOW RESISTANCE AND ALL TESTS WERE PASSED. COMPLAINT SAMPLE WAS DECONTAMINATED AND RECEIVED AT VYAIRE HELSINKI SITE. SAMPLE WAS UNPACKED, VISUALLY INSPECTED AND TESTED FOR FLOW RESISTANCE. IT WAS DISCOVERED IN VISUAL INSPECTION THAT THE USED OPA DECONTAMINATION SOLUTION HAD ENTERED THE HME FOAM AND FILTER. AFTER VISUAL INSPECTION SAMPLE WAS TESTED FOR FLOW RESISTANCE WITH 30L/MIN FLOW. AS THE FLOW WAS APPLIED TO THE SAMPLE SOME OF THE OPA SOLUTION CAME OUT OF THE SAMPLE. INITIAL RESULT OF THE FLOW RESISTANCE TEST FOR THE SAMPLE AT 30L/MIN WAS 1,874KPA. AFTER SOME OF THE OPA SOLUTION WAS FLUSHED OUT OF THE HMEF THE FLOW RESISTANCE READING DROPPED TO 0,866KPA. BOTH OF THESE ARE CLEARLY HEIGHTENED FLOW RESISTANCE TEST RESULTS COMPARED TO UNUSED PRODUCT FLOW RESISTANCE WHICH IS IN THE RANGE OF ~0,9-1,1KPA WHICH WAS ALSO EVIDENCED BY TESTING 5 NEW SAMPLES. THE HIGHER FLOW RESISTANCE VALUE IS LOGICAL AND EXPECTED AS THE PRODUCT HAS BEEN SOAKED IN THE DECONTAMINATION FLUID. WITH THE TEST RESULTS NO EVIDENCE OF DESIGN OR MANUFACTURING DEFECT IN THE PRODUCT CAN BE CONCLUDED. THE PERFORMANCE OF THE SAMPLE PRODUCT HAS BEEN IMPACTED BY THE DECONTAMINATION METHOD AND THUS THIS COMPLAINT INVESTIGATION CANNOT PROVIDE ANY RELIABLE RESULT FOR COMPLAINT ROOT CAUSE ANALYSIS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. INITIAL DEVICE ANALYSIS FOUND THAT THE VENTILATOR SHOWED NO SYSTEM ERROR. NO EXACT ROOT CAUSE COULD BE DETERMINE AT THIS TIME SINCE THE INVESTIGATION IS STILL ONGOING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR ALARMS ON HIGH PRESSURE, LOW MINUTE VENTILATION, SET-ALARM-UNDERSHOOT WERE GENERATED. THE DOCTOR DISCHARGED THE PATIENT FROM THE VENTILATOR AND SWITCHED TO AN AMBU BAG, BUT THE PATIENT PASSED AWAY 20 MINUTES LATER. THE CUSTOMER CONFIRMED THAT DUE TO THE PATIENT'S PRE-EXISTING HEALTH CONDITION, ACUTE EXACERBATION OF PNEUMOCONIOSIS, HE WAS UNABLE TO SURVIVE. BUT THE PHYSICIAN BELIEVES THAT THE OCCLUSION OF HMEF PLAYED A ROLE IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224845 AIRLIFEHMEF 750/S, DISPOSABLE FILTER, BACTERIAL, BREATHING-CIRCUIT CAH VYAIRE MEDICAL AIRLIFE¿HMEF 750/S, DISPOSABLE 0207321 10885403284151

    Patients

    Seq Age Sex Outcome Treatment
    1 Death