—#48577

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 0033, 0034, 0036, 0038, 0041 through 0043, 0045, 0047 through 0049, 0052, 0054, 0055, 0057, 0058, 0061, 0063, 0064, 0069, 0072, 0075 through 0096, 0098, 0099, 0102 through 0116, 0118, 0124, 0127 through 0136, 0138 through 0146, 0148 through 0151, 0153 through 0163, 0165 through 0170, 0172, 0173, 0175, 0179, 0181 through 0187, 0189 through 0200, 0202 through 0231, 0233 through 0240, 0242 through 0278, 0281 through 0302, 0304 through 0481, 0483 through 0587, 0700 through 0753, 0757, 0758, 0760 through 0769, 0771 through 0787, 0789 through 0793, 0795 through 0866, 0868 through 0898, 0900 through 0921, 0923 through 0978, 0980 through 1001, 1004 through 1015, 1017, 1019 and 1024 through 1027.

Why it was recalled

Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.

Root cause (FDA determination)

Other

Action the firm took

U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error. International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA and countries 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: 2004-10-12
Posted by FDA: 2006-12-30
Terminated: 2007-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.