Terumo Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns " or similar equipment.
FDA Recall Z-1969-2013 · Posted 2013-08-14
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2013-07-26
Date Terminated2017-02-07
Product Quantity1657
Reason for Recall
The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
Firm Action
Terumo CVS, sent an URGENT MEDICAL DEVICE RECALL notification letter dated July 26, 2013, to all affected customers explaining the correction to the operators manual, potential hazards and what to do in response to the issue.
If you have any questions or concern please contact Terumo CVS Customer Service 1-800-521-2818 Recall Fax 1-734-741-6149 Customer Service Hours:
Monday Friday, 8 AM - 6 PM ET
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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