—#110339

Product

System 1 Base 100/120V 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 equipment.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.

Why it was recalled

Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is

Root cause (FDA determination)

Equipment maintenance

Action the firm took

The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" notification dated June 25, 2012 and an update to the Operator's Manual for the Terumo Advanced Perfusion System 1 via Federal Express to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review this Medical Device Recall notice; assure that all users are aware of this notice; place the addendum at the beginning of the Roller Pumps Section (page 5.1) of the Operator's Manual, and complete and return the attached Customer Response Form to the fax number/email address indicated on the form. Note: Terumo is continuing its investigation into the root cause of the malfunctions, and may initiate further action pending results of the investigation. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours: Monday-Friday, 8 AM - 6 PM (ET).

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and countries including: Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

Timeline

Recall initiated: 2012-06-25
Posted by FDA: 2012-07-09
Terminated: 2015-09-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.