Recall Z-0883-2011 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
| Date | Jan 7, 2011 (initiated Dec 2, 2010) |
| Status | Terminated |
| Reason | The firm identified that a component within the System 1 ABD and Occluder Modules that may malfunction. The Air Bubble Detector Module (ABD) is used with an air sensor to detect gross air bubbles in the perfusion circuit. The Occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line. The firm identified a fai |
| Root cause | Component design/selection |
| Action | Terumo Cardiovascular Systems Corporation issued an URGENT MEDICAL DEVICE CORRECTION letter dated 12/2/2010 to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager. The letter identified the product, the problem, and the action to be taken. The letter stated the firm will replace all modules in the affected population, and that a representative would contact the consignee regarding the replacement schedule. Customers were to review the Medical Device Correction. Assure that all user were aware of the notice. Confirm receipt of the communication by faxing the atta |
| Quantity | 221 devices |
| Distribution | Worldwide Distribution - US, Austrailia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Guatamala, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Phillipines, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, and Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.