Recall Z-0302-2012 · DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

Terumo Cardiovascular Systems Corporation

Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipme

Date	Nov 29, 2011 (initiated Nov 10, 2011)
Status	Terminated
Reason	Terumo CVS discovered that our In house service center has incorrectly installed a felt washer into the main bearing of nine roller pumps that had been returned for repair or preventative maintenance unrelated to the felt washer. The felt washer was added as a validated running change to production to all roller pumps manufactured since February 2009. The felt washer should not have been installed
Root cause	Nonconforming Material/Component
Action	Terumo sent an URGENT MEDICAL DEVICE REMOVAL notification letter dated November 10, 2011 to all affected customers. The letter described the affected products, problem, potential hazards, and important clinical information. Replacement roller pumps will be configured at the customer site by a Terumo Field representative with the affected roller pumps being returned via normal returned goods process. Customers were asked to complete the attached response form and fax to the number indicated on the form. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818.
Quantity	3 units
Distribution	Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K022947

ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
Terumo Cardiovascular Systems Corp., Mar 20, 2003