BEUDAMED
    FDA Recall Open, Classified

    Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,

    Recall: Z-0562-2022 · Initiated December 7, 2021

    Recall

    Recall Number
    Z-0562-2022
    Event Number
    89369
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    QJZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 7, 2021
    Address
    920 Winter St, Bld 950, Waltham, MA, 02451-1521

    Description

    Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,

    Reason

    Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.

    Action

    Fresenius Medical Care issued Urgent Medical Device Correction Letter ( Novalung Sensor Box P/N F30000163 FA-2021-33-C) on 12/7/21 via USPS First Class Mail. Letter sates reason for recall, health risk and action to take: In the rare event 206/208 alarms occur, you may silence the alarms intermittently using the audio pause button. If you have continued alarms, it is recommended to replace either the sensor box or the entire console if a secondary or backup sensor box is available. Reference section 6.2 of the Instructions for Use (Part Number US (Part Number US-003-2019-08). If available, switch to a backup sensor box. To correct this issue, FMCRTG will update the sensor box on your Novalung console. An FMCRTG Field Service Technician will be contacting you to schedule this correction. For questions or concerns, please contact your local sales representative or FMCRTG Technical Support Services at 800-405-1321.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.

    Quantity

    115 units