BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 15442701 · Received September 16, 2022

    Report

    Report Number
    3010532612-2022-00358
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 12, 2022
    Report Date
    August 19, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    30801902051722
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ON THE EVENING OF (B)(6) , THE EQUIPMENT WAS PUT INTO USE. ON THE MORNING OF AUGUST 13, IT WAS FOUND THAT THERE WAS NO GAS IN THE HELIUM CYLINDER. THE HOSPITAL URGENTLY BORROWED A BOTTLE OF HELIUM FROM (B)(6) HOSPITAL FOR REPLACEMENT, AND THE AGENT (B)(4) . ALSO SENT SOMEONE TO DRIVE A BOTTLE FROM (B)(6) FOR STANDBY. THE DEVICE WAS STOPPED FOR ABOUT 1 HOUR. AT ABOUT 5:00 P.M. ON AUGUST 13, THE DOCTOR FOUND THAT THE PRESSURE OF THE HELIUM GAS REPLACED IN THE MORNING HAD DROPPED TO LESS THAN 100PSI. HE CHECKED THE GASKET OF THE GAS CYLINDER AND THE GAS TRANSFER VALVE OF THE HELIUM CYLINDER, AND NO PROBLEM WAS FOUND. AFTER REPLACING THE WHOLE BOTTLE OF HELIUM, HE FOUND THAT THE GAS DROPPED RAPIDLY, AND IT WAS SUSPECTED THAT THE GAS PRESSURE REDUCING VALVE WAS FAULTY. AT 1:00 P.M. ON AUGUST 14, THE ENGINEERS OF NANJING QUANKANG TRADING CO., LTD. A RRIVED AT THE HOSPITAL AND REPLACED THE PRESSURE REDUCING VALVE ON THE HOSPITAL MACHINE WITH THE PRESSURE REDUCING VALVE ON THE COMPANY'S SAMPLE MACHINE. AFTER TESTING FOR 1 HOUR, THE GAS PRESSURE DROPPED BY 2PSI, WHICH WAS WITHIN THE NORMAL RANGE. WHEN THE EQUIPMENT WAS WORKING UNTIL NOON ON THE 14TH, THE GAS PRESSURE DROPPED BY 5 PSI, WHICH WAS WITHIN THE NORMAL RANGE. AT 17:30 ON AUGUST 15, THE MACHINE WAS REMOVED AND THE PATIENT WAS IN GOOD CONDITION". ADDITIONAL INFORMATION RECEIVED STATED THAT NO MEDICAL INTERVENTION WAS NECESSARY WHEN THE PRESSURE DROPPED AND WHEN THE DEVICE STOPPED FOR ABOUT ONE HOUR. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ON THE EVENING OF (B)(6), THE EQUIPMENT WAS PUT INTO USE. ON THE MORNING OF (B)(6), IT WAS FOUND THAT THERE WAS NO GAS IN THE HELIUM CYLINDER. THE HOSPITAL URGENTLY BORROWED A BOTTLE OF HELIUM FROM THE FIRST HOSPITAL OF NANTONG CITY FOR REPLACEMENT, AND THE AGENT NANJING QUANKANG TRADING CO., LTD. ALSO SENT SOMEONE TO DRIVE A BOTTLE FROM SUZHOU FOR STANDBY. THE DEVICE WAS STOPPED FOR ABOUT 1 HOUR. AT ABOUT 5:00 P.M. ON (B)(6), THE DOCTOR FOUND THAT THE PRESSURE OF THE HELIUM GAS REPLACED IN THE MORNING HAD DROPPED TO LESS THAN 100PSI. HE CHECKED THE GASKET OF THE GAS CYLINDER AND THE GAS TRANSFER VALVE OF THE HELIUM CYLINDER, AND NO PROBLEM WAS FOUND. AFTER REPLACING THE WHOLE BOTTLE OF HELIUM, HE FOUND THAT THE GAS DROPPED RAPIDLY, AND IT WAS SUSPECTED THAT THE GAS PRESSURE REDUCING VALVE WAS FAULTY. AT 1:00 P.M. ON (B)(6) 2022 THE ENGINEERS OF NANJING QUANKANG TRADING CO., LTD. A RRIVED AT THE HOSPITAL AND REPLACED THE PRESSURE REDUCING VALVE ON THE HOSPITAL MACHINE WITH THE PRESSURE REDUCING VALVE ON THE COMPANY'S SAMPLE MACHINE. AFTER TESTING FOR 1 HOUR, THE GAS PRESSURE DROPPED BY 2PSI, WHICH WAS WITHIN THE NORMAL RANGE. WHEN THE EQUIPMENT WAS WORKING UNTIL NOON ON THE (B)(6), THE GAS PRESSURE DROPPED BY 5 PSI, WHICH WAS WITHIN THE NORMAL RANGE. AT 17:30 ON (B)(6) 2022, THE MACHINE WAS REMOVED AND THE PATIENT WAS IN GOOD CONDITION". ADDITIONAL INFORMATION RECEIVED STATED THAT NO MEDICAL INTERVENTION WAS NECESSARY WHEN THE PRESSURE DROPPED AND WHEN THE DEVICE STOPPED FOR ABOUT ONE HOUR. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222171 AUTOCAT 2 SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000302 N/A 30801902051722

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown