Recall Z-2443-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD 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 or similar equipment.
| Date | Sep 24, 2012 (initiated Sep 10, 2012) |
| Status | Terminated |
| Reason | Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unli |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | Terumo CVS issued an URGENT MEDICAL DEVICE Recall letter dated September 10, 2012 to alert all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Terumo CVS representative will contact all affected US account.to schedule an appointment to replace the affected product. The affected product will be return to Terumo for destruction. Non-US Terumo Affiliates will be instructed to remove the devices from the field and provide a record of destruction. For questions call the Terumo CVS Customer Service at 1-800-521-2818 |
| Quantity | 150 units |
| Distribution | Worldwide and US Nationwide Distribution |
| 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 |