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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: 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.
Recall Number Z-2443-2012
Classification Class II
Code Info Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.
Product Distributed Qty 150 units
Reason For Recall Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo® Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unlikely that the failure would recur. The failure only occurs when there is no tubing installed in the flow sensor, therefore the only risk to the patient is if the false alarm somehow delays the surgical procedure. There are no known reports of patient injury as a result of this issue.

Event Detail

Event Id 62313
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide and US Nationwide Distribution