Class 2 Device Recall Cogent Hemodynamic Montoring System

• Date Initiated by Firm: November 09, 2020
• Create Date: January 14, 2021
• Recall Status: Terminated on April 19, 2023
• Recall Number: Z-0859-2021
• Recall Event ID: 86816
• 510(K)Number: K152006
• Product Classification: Computer, diagnostic, pre-programmed, single-function - Product Code DXG
• 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.
• Code Information: 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 TSH901575 TSH901655 TSH901608 TSH901984 TSH901599 TSH901579 TSH900423 TSH901664 TSH901617 THS901633 TSH901624 TSH901592 TSH901582 TSH901649 TSH901673 TSH901672 TSH901591 TSH901611 TSH901584 TSH901646 TSH901645 TSH901605 TSH901667 TSH901990 TSH901586 TSH901587 TSH901625 TSH901989 TSH901635 TSH900432 TSH901571 TSH101370 TSH200749 TSH900420 TSH200775 TSH200826 TSH200799 TSH900414 TSH901651 TSH200759 TSH901986 TSH901650 TSH901621 TSH901596 TSH901613 TSH901616 TSH900430 TSI701162 TSI701134 TSFA01681 TSH101383 TSH200820 TSH101364 TSH200765 TSH900433 TSH901631 TSI701138 TSH101365 140371 TSI802258 140123 140137 TSI701144 TSI701170 TSI701143 TSI701171 TSI701133 TSI701172 TSI701175 TSI701166 TSI701145 TSI701164 TSI701153 TSI701147 TSI701146 TSI701148 TSI701154 TSI701152 TSI701149 TSI701150 TSI701151 TSI701131 TSI701132 TSI701160 TSI701157 TSI701176 TSI701165 TSI701155 TSI701156 TSI701159 TSI701158 TSI701141 TSI701190 TSI701124 TSI701122 TSI701123 TSI701161 TSI701187 TSI701168 TSI701167 TSI701137 TSI701130 TSI701139 TSI701140 TSI701126 TSI701183 TSI701182 TSI701163 TSI900323 TSI802215 TSI900324 TSI802208 TSI802207 TSI802261 TSI802262 TSI900348 TSI802225 TSI900312 TSI701181 TSI802226 TSI802213 TSI900310 TSI900378 TSI802251 TSI900335 TSI900377 TSI900367 TSI900369 TSI802169 TSI900353 TSI900365 TSI900347 TSI900366 TSI900364 TSI900338 TSI900361 TSI900293 TSI900326 TSI900294 TSI900327 TSI900325 TSI900292 TSI802229 TSI802172 TSI900339 TSI802228 TSI900328 TSI900349 TSI900321 TSI900319 TSI802247 TSI900330 TSI900320 TSI802248 TSI802246 TSI802240 TSI802200 TSI902201 TSI802241 TSI802242 TSI802199 TSI802176 TSI802175 TSI701117 TSI701116 TSI701118 TSI900309 TSI900381 TSI900379 TSI900308 TSI900309 TSI900307 TSI900304 TSI900305 TSI900306 TSI701104 TSI701089 TSI701091 TSI701090 TSI900322 TSI900376 TSI900362 TSI802174 TSI900363 TSI701075 TSI701074 TSI701076 TSI701103 TSI701102 TSI701101 TSI701097 TSI701096 TSI701094 TSI701064 TSI701063 TSI701062 TSI701072 TSI701073 TSI701071 TSI701069 TSI701068 TSI701084 TSI701070 TSI701083 TSI701085 TSI701080 TSI701081 TSI701058 TSI701056 TSI701079 TSI701077 TSI701061 TSI701067 TSI701088 TSI701078 TSI802186 TSI900318 TSI802220 TSI900382 TSI802221 TSI900375 TSI802254 TSI802253 TSI802206 TSI802205 TSI802204 TSI900331 TSI802211 TSI802252 TSI900356 TSI802210 TSI802212 TSI900373 TSI701086 TSI802219 TSI900693 TSI701087 TSI900332 TSI802187 TSI900316 TSI900317 TSI900384 TSI802188 TSI802235 TSI802234 TSI900355 TSI802233 TSI900345 TSI802203 TSI802202 TSI900371 TSI900372 TSI802194 TSI900370 TSI900300 TSI802232 TSI802231 TSI900359 TSI900360 TSI900298 TSI802223 TSI900358 TSI802189 TSI900299 TSI802190 TSI802191 TSI802193 TSI802222 TSI802224 TSJB01598 TSJ900768 TSI802216 TSI802217 TSI802218 TSI900297 TSI900296 TSI900295 TSI802237 TSI802239 TSI802177 TSI802178 TSI900386 TSI802179 TSI900385 TSI900387 TSI802255 TSI802257 TSI802166 TSI802165 TSI900303 TSI802198 TSI802197 TSI802196 TSI900302 TSI900301 TSI802167 List Number/Item Code: 58400-000R User Interface Module item: 58403-000 Serial Number: TSH900425 TSFA01656 TSFA01696 TSH101361 TSH900451 TSH901618 TSI701111 TSH901574 TSFA01686 TSH101341 TSH101349 TSH200742 TSH200821 TSH200810 TSH900419 TSH200783 TSH900408 TSH200786 TSFA01697 TSH200770 TSH101391 TSH200748 TSFA01666 TSH200819 THS101345 TSH900402 TSH900447 TSH200769 TSH101382 TSH200822 TSH101344 TSFA01687 TSFA01677 TSH101338 TSH200758 TSH200744 TSFA01659 TSH101373 TSH200792 TSFA01667 TSH200824 TSH200739 TSH200787 TSI900357 TSH200768 TSFA01665 TSH101354 TSH900405 TSH200812 TSH900404 TSH900439 TSH900403 TSH900445 TSH901665 TSH101377 TSH200785 TSH200779 TSHI701057 TSFA01657 TSH200796 TSH200808 TSH900416 TSH200762 TSH200784 TSH101389 TSH200778 TSH200766 TSH200811 TSH200830 TSH900436 TSH900426 TSH900437 TSH200774 TSH101356 TSH101361 TSI701109 TSH200788 TSI701082 TSH200803 TSH101344 TSH101375 TSH200790 TSH200791 TSH200756 TSH200829 TSH900427 TSH200789 TSH900412 TSH200747 TSH200745 TSH900421 TSH200823 TSH900415 TSH900435 TSH101359 TSH900450 TSH900440 TSH901663
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• Manufacturer 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: 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
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXG