—#48742

Product

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Serial numbers 0029, 0031 through 0043, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0068, 0070 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0111, 0113 through 0117, 0120 through 0123, 0125 through 0180, 0182 through 0191, 0194, 0195, 0197-0207, 0209, 0211 through 0527, 0700 through 0725, 0727, 0730 through 0878, 0880, 0881, 0883 through 0977, 0981 through 0990, 0992, 0993, 0995 through 1266, 1268 through 1528, 1539 through 1579, 2000 through 2018, 2023, 2025, 2027 through 2057 and 2072 through 2083.

Why it was recalled

The roller pump will pause in response to a pressure alarm condition, as designed, but then may not resume operation as expected after the alarm condition has been cleared.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Worldwide distribution ---- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

Timeline

Recall initiated: 2006-10-16
Posted by FDA: 2007-02-14
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48742. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.