—#48741

Product

Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040.

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 0030, 0033, 0034, 0036, 0037, 0038, 0041, 0042, 0043, 0045 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075-0096, 0098 through 0119, 0122, 0124, 0125, 0127 through 0163, 0165 through 0170, 0172, 0173, 0175, 0177, 0179, 0181, 0182 through 0231, 0233 through 0278, 0280 through 0481, 0483 through 0587, 0700 through 0753, 0757 through 0766, 0768, 0769, 0771 through 0787, 0789 through 0793, 0795 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1028, 1030 through 1051, 1053 through 1075, 1079 through 1268, 1270 through 1936, 1947 through 1951, 2000 through 2029, 2033, 2034, 2036 through 2038, 2042 through 2182 and 2186 through 2205.

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 #48741. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.