ClearanceBrief
Recall Z-1978-2013 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

Terumo Cardiovascular Systems Corporation

220/240V AC, Advanced Perfusion System 1 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 TM or similar equipment.

DateAug 15, 2013 (initiated Jul 26, 2013)
StatusTerminated
ReasonTCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transducer from the system.
Root causeSoftware design
ActionTerumo sent an Urgent Medical Device Recall notification letter dated July 26, 2013 to all affected customers. The letter identified the affected product, reason for correction, potential hazards of the recall issue, the correction to be implemented, and customer instructions for replying to the recall notification. Terumo CVS is providing an addendum to be placed in the Operator's Manual at the beginning of Chapter 7, Modules. Questions or concerns are directed to Terumo CVS Customer Service at 1-800-521-2818, Recall Fax 1-877-275-6860. Customer Service hours are Monday to Friday 8am-6pm
Quantity1657
DistributionWorldwide Distribution - US Nationwide in the states of :AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022947ADVANCED 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