BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINISPACER

    MDR report key: 8438965 · Received March 20, 2019

    Report

    Report Number
    2026894-2018-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    October 22, 2018
    Report Date
    March 20, 2019
    Manufacturer
    THAYER MEDICAL CORPORATION
    Product Code
    CAI
    PMA / PMN Number
    K901739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THAYER HAS ATTEMPTED BUT BEEN UNABLE TO GET ANY ADDITIONAL INFORMATION ABOUT THIS INCIDENT FROM (B)(6). ON (B)(6) 2018, (B)(6), INFORMED THAYER THAT (B)(6) HAD DETERMINED THAYER'S MINISPACER WAS NOT RESPONSIBLE FOR PATIENT ADVERSE EVENT. SHE ALSO DID NOT RESPOND TO FURTHER INQUIRIES BY THAYER ON PATIENT STATUS.

    Description of Event or Problem · 1

    (B)(6) EMPLOYEE, (B)(6), REPORTS TO THAYER THAT ONE OF THEIR NURSES SET UP A NON-INVASIVE VENTILATOR CIRCUIT FOR A PATIENT WHO WAS TO BE RELEASED FROM THE HOSPITAL AND RETURN HOME FOR A FOLLOW-UP OXYGEN BREATHING TREATMENT VIA TRACHEA. EQUIPMENT ASSEMBLED BY THE NURSE INCLUDED AN AIR COMPRESSOR, AN OXYGEN CONCENTRATOR WITH CONNECTED TUBING AND A THAYER MINISPACER DEVICE FOR IN-LINE MDI TREATMENT. THE NURSE CONNECTED THE OUT-GOING OXYGEN TUBING TO THE IN-GOING ACTUATOR PORT OF THE MINISPACER WITH INTENT TO INTRODUCE CONCENTRATED OXYGEN INTO THE PATIENTS AIRWAY. THIS IS NOT THE INTENDED USE OF THE MINISPACER. (B)(6) ALSO STATED THAT ONCE THE PATIENT WAS HOME AGAIN AND CONNECTED TO THE CIRCUIT, THE NURSE WAS CERTAIN THE PATIENT WAS RECEIVING OXYGEN AS INTENDED UP TO AND INCLUDING A FLOW RATE OF 4 L/MIN. ONCE THE NURSE INCREASED FLOW TO 6 L/MIN, THERE WAS SOME (UNSTATED) INDICATION THAT THE FLOW WAS TOO HIGH AND THE PATIENT WAS LIKELY NOT RECEIVING A FULL 6 L/MIN OF CONCENTRATED OXYGEN. (B)(6) INFORMED THAT THE PARAMEDICS WERE CALLED WHEN THERE APPEARED TO BE A PROBLEM WITH THE PATIENT'S TRACH. WHEN THE PARAMEDICS ARRIVED, ONE OF THE EMT'S OBSERVED THE "OXYGEN PORTAL" INTO THE VENT LINE AND STATED THAT THE ADAPTER WAS NOT TO BE USED AT A FLOW RATE AS HIGH AS 6 L/MIN AS IT CANNOT HANDLE IT. IT APPEARS THAT BOTH THE NURSE AND THE EMT THOUGHT THE MLNISPACER WAS AN IN-LINE OXYGEN ADAPTER. REGARDLESS OF THEIR PACKAGING DIFFERENCES, APPARENTLY THE ACTUAL DEVICES LOOK VISUALLY SIMILAR. (B)(6) EXPLAINED THAT THE PATIENT WAS TAKEN LO THE HOSPITAL BECAUSE OF THE NEED FOR A REPAIR TO HIS TRACH, NOT DUE TO IN APPROPRIATE OXYGENATION. THAYER HAS BEEN ADVISED THAT THE PATIENT IS CURRENTLY UNDERGOING SURGERY TO REPAIR THE TRACH AND THERE IS NO FURTHER UPDATE AT PRESENT (12:30 PM, (B)(6) 2018).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228623 MINISPACER VENTILATOR ADAPTER FOR METERED DOSE INHALERS CAI THAYER MEDICAL CORPORATION 1021 070345

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization