icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
Recall
- Recall Number
- Z-0859-2021
- Event Number
- 86816
- Firm
- ICU Medical, Inc.
- FEI Number
- 2025816
- Product Code
- DXG
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 9, 2020
- Terminated
- April 19, 2023
- Address
- 951 Calle, Amanecer San Clemente, CA, 92673-6212
Description
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
On 11/09/2020, the firm's sent an "URGENT: MEDICAL DEVICE CORRECTION" Notice via traceable mailing informing them that the Recalling Firm has identified a software issue with it Hemodynamic Monitoring System which could potentially display the incorrect continuous cardiac output (COO) values after calibration. The Recalling Firm is informing it customer that if the following calibration steps are taken: Step 1: Start PulseCO monitoring by pressing the CCO button which forces a zeroing of the arterial pressure waveform; press zero on Cogent then reinitiate arterial pressure monitoring. Step 2: Wait for the PulseCO cardiac output value to stabilize. Step 3: If the displayed PulseCO value is different than expected, apply a desired calibration value that is different from the nominal PulseCO value. Step 4: The calibration value will be displayed in 10-20 seconds or less from the time of entry. Two potential situations can occur in relation to the calibration process: Situation 1: If PulseCO monitoring is stopped after Step 3 and before the PulseCO value reaches the desired calibration-value in Step 4, followed by pressing the CCO button to restart PulseCO monitoring, in some cases the displayed PulseCO will not reach the desired calibration-value previously entered. The displayed CCO value will be neither the original value nor the desired calibrated value; but rather it will be a value between the two. Situation 2: After completion of Steps 1 4, if PulseCO monitoring is stopped and then an OpMod with a different patient ID stored on it is connected, the Cogent will display the Patient Selection screen. On the Patient Selection screen, the user selects Current Patient and then presses the CCO button to re-start the PulseCO monitoring. In some cases, the displayed PulseCO will not reach the desired calibration value previously entered and could be higher or lower than the entered value. The required actions for Users: There is no need to discontuine use
U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None
220 units