Recall Z-2056-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V 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.
| Date | Jul 20, 2012 (initiated Jun 22, 2012) |
| Status | Terminated |
| Reason | 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 | Equipment maintenance |
| Action | 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 |
| Quantity | 640 devices |
| Distribution | 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, Philippin |
| 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 |