Class 2 Device Recall Terumo Advanced Perfusion System 1 Flow Module

• Date Initiated by Firm: January 19, 2018
• Create Date: April 20, 2018
• Recall Status: Terminated on July 18, 2018
• Recall Number: Z-1478-2018
• Recall Event ID: 79624
• 510(K)Number: K172220
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.
• Code Information: Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: Mary Swift; 734-741-6056
• Manufacturer Reason for Recall: Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
• FDA Determined Cause: Employee error
• Action: The firm notified customers via phone alerting them of this affected device, issue, potential hazard, correction, and instructions. The communication also included scheduling an expedited service call for a Field Service Technician to replace the affected Flowmeter Module with a corrected Flowmeter Module. When necessary to avoid delaying or cancelling life-sustaining surgery, users can continue to use the Flowmeter Module while awaiting replacement. Once the issue is recognized by the user, if a replacement Flowmeter Module is available, replacement and reassignment of safety connections of the Flowmeter Module can be accomplished in less than 15 seconds. In the event that a replacement Flowmeter Module is not available, a less common mitigation is the use of a back-up stand-alone centrifugal pump or a stand-alone ultrasonic flowmeter system to provide flow data. Customers should receive a copy of the Urgent Medical Device Recall phone script by e-mail along with a Customer Response Form. The e-mail should be reviewed, and the form completed and returned as indicated. Questions or concerns can be directed Terumo CVS Customer Service at 1-800-521-2818.
• Quantity in Commerce: 7
• Distribution: Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.
• 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