Recall Z-0859-2021
ICU Medical, Inc. · initiated November 9, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI701136 TSI701180 TSI701179 TSH901670 TSH200797 TSH901640 TSH900431 TSI701174 TSH200801 TSH200767 TSI701173 TSI802195 TSH101376 TSH200764 TSH901982 TSH901985 TSH901602 THS901630 TSH901576 TSH901639 TSH901622 TSH901641 TSH901620 TSH901604 TSH901988 TSH901595 TSH901597 TSH901588 TSI701113 TSI701112 TSI701110 TSI701115 TSI701105 TSH900444 TSH900449 TSH901612 TSH901610 TSI701177 TSI701178 TSI701125 TSI701127 TSI701184 TSI701185 TSI701186 TSI701169 TSI701128 TSFA01684 TSFA01695 TSH101367 TSH901666 TSI701119 TSI701120 TSH901642 TSH901674 TSH901662 TSH901626 TSH901644 TSH901627 TSH901572 TSFA01683 TSH101379 TSH901643 TSH200798 TSH900438 TSH900411 TSH901594 TSH901991 TSH200832 TSH901648 TSH101337 TSH200780 TSH200763 TSH900406 TSH900409 TSH200802 TSH900434 TSH901581 TSH901636 TSH901632 TSH901619 TSH901647 TSH900446 TSH101358 TSH901615 TSH900417 TSH900442 TSH900429 TSH901987 TSH901609 TSH901590 TSH901638 TSI701106 TSI701107 TSI701100 TSI701121 TSFA01661 TSH101350 TSH200804 TSH200805 TSH101352 TSH101342 TSH101340 TSH101360 TSH900441 TSH901634 THS901589 TSH901573 TSH901603 TSH901657…
Reason for recall
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
FDA-determined cause: Software design
Action taken
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
Details
- Recall number
- Z-0859-2021
- Initiated
- November 9, 2020
- Terminated
- April 19, 2023
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Quantity
- 220 units
- Distribution
- 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
- Recalling firm
- ICU Medical, Inc., San Clemente, CA