Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor,

FDA device recall Z-1566-2011 · posted 2011-03-07 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' investigation has determined that

Action taken

Terumo sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 14, 2011, addressed to Chief of Perfusion, Department of Cardiovascular Surgery or Director of Operationd Room Services. The letter explains the problem with the circuit breakers and hazards of the problem. The letter states that a service technician will visit the facility to install a guard. The service will be performed at the next scheduled preventative maintenance visit for those consignees with a service contract. For customers without a service contract, Terumo CVS will contact the consignees to schedule an appointment for the correction. Customers were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions or concerns customers were instructed to contact Terumo CVS Customer Service at 1-800-521-2818.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

728 devices.

Distribution

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, ME, MI, MO, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and the

Date initiated

2011-02-14

Date posted

2011-03-07

Date terminated

2012-03-20

Location

Ann Arbor, MI

Related 510(k) clearances