—#110373

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) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application

Root cause (FDA determination)

Equipment maintenance

Action the firm took

TERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, and an update to the Operator's Manual via Federal Express to inform consignees of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of backup system availability. Consignees were instructed to review the Medical Device Correction notice, assure that all users are aware of the notice. Place the Addendum at the beginning of the Centrifugal System Section of the Operator's Manual, Confirm receipt of the communication by faxing or emailing a completed Customer Response Form as indicated on the form. For any questions customers should call 1-800-521-2818.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

Timeline

Recall initiated: 2012-06-22
Posted by FDA: 2012-07-20
Terminated: 2013-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110373. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.