—#110221

Product

Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K915183
Affected lot / code info: catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.

Why it was recalled

Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

TERUMO Cardiovascular Systems communicated with their affiliate, Terumo Dubai, in 2009 at the time the complaints were reported. No further communication was warranted. For questions regarding this recall call 734-741-6173.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: International only-country of: Terumo Dubai, UAE

Timeline

Recall initiated: 2009-08-12
Posted by FDA: 2012-09-11
Terminated: 2013-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.