Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1 Flow Module

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Terumo Advanced Perfusion System 1 Flow Module see related information
Date Initiated by Firm January 19, 2018
Create Date April 20, 2018
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = Terumo Cardiovascular Systems Corporation
-
-