Recall Z-0563-2011 ยท JOR Generator, Pulsatile Flow, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corporation
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
| Date | Dec 8, 2010 (initiated Nov 2, 2010) |
| Status | Terminated |
| Reason | The system 8000 roller pumps may fail resulting in a persistent pump stop. |
| Root cause | Other |
| Action | The firm sent "URGENT MEDICAL DEVICE CORRECTION" dated 11/02/2010 to customers. The letter describes the product, problem and corrective actions taken and/or needed to be taken by the customers. The letter states the system responds to a failed inductor by displaying an overspeed message and stopping the roller pump without an audible alert. The pump cannot be restarted. The customers/users are instructed to stop the pump, replace the pump with a backup or if necessary use the handcrank. The letter states that Terumo will replace the roller pump at the next preventative maintenance visit |
| Quantity | 95 devices both products |
| Distribution | Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915183 | SARNS 8000 MODULAR PERFUSION SYSTEM 3M Health Care, Sarns, Jul 8, 1992 |