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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS)

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  Class 2 Device Recall Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS) see related information
Date Initiated by Firm October 17, 2018
Create Date June 11, 2019
Recall Status1 Terminated 3 on April 30, 2020
Recall Number Z-1769-2019
Recall Event ID 82878
510(K)Number K172220  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
Code Information 01338 01339 01340 01341 01342 01349 01350 01351 01352 01353 01354 01355 01356 01357 01358 01360 01361 01362 01363 01365 01366 01367 01369 01370 01371 01372 01373 01374 01375 01376 01377 01378 01379 Lot/Serial 01380 01381 01382 01383 01384 01385 01386 01387 01388 01389 01394 01395 01396 01397 01398 01405 01406 01407 01408 01410 01411 01413 01414 01415 01416 01418 01420 01421 01422 01423 01424 01425 01426 Lot/Serial 01427 01428 01429 01430 01431 01432 01434 01435 1718 2317 4417 9999  UDI 00886799000588
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
Manufacturer Reason
for Recall
An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
FDA Determined
Cause 2
Process control
Action On October 17, 2018, the firm notified customers of the recall via Urgent Medical Device Recall letter. The letter alerted customers that the devices were assembled with stepper motors that did not meet supplier specifications. Customers were informed that in the event of a failure, the gas system flow and FiO2 control sliders on the Central Control Monitor would be disabled and the gas system could only be controlled by the local control knobs. Customers were asked to take the following actions: 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Terumo CVS will contact users to schedule the field correction activities. Note: Terumo CVS recommends that users continue using Terumo System 1 while waiting for this correction. If you have any questions, please contact Terumo CVS Customer Service: 1.800.521.2818, Monday  Friday, 8 a.m.  6 p.m. ET Recall Fax: 1.734.741.6149
Quantity in Commerce 72
Distribution Distribution US nationwide, including CA, CT, IL, IN, KY, MI, MN, MO, MT, NM, NY, OH, and WI. Foreign distribution to Canada, Mexico, and South Korea.
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 = DTQ and Original Applicant = Terumo Cardiovascular Systems Corporation
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