—#95648

Product

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.

FDA product code: JOR — Generator, Pulsatile Flow, Cardiopulmonary Bypass
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K915183
Affected lot / code info: Lots 19937-19944, 19955-19984, 20005-20029, 20035-20038 and 20047.

Why it was recalled

The system 8000 roller pumps may fail resulting in a persistent pump stop.

Root cause (FDA determination)

Other

Action the firm took

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 - or sooner- if the customer has a service contract. If the customer does not have a service contract, Terumo will contact the customer within 2 weeks to set up an appointment for the service. Terumo CVS expects all affected inductors to be replaced to be replaced within three months. Call Terumo CVS Customer Service upon completion of the case at 800-521-2818. The customer was also instructed to complete and return the enclosed CUSTOMER RESPONSE FORM Please note that we are not recommending that you stop using the roller pumps for your Sarns system 8000. For any questions, call toll free 800-262-3304 or phone 734-663-4145.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.

Timeline

Recall initiated: 2010-11-02
Posted by FDA: 2010-12-08
Terminated: 2011-10-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95648. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.