—#48576

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 0031, 0032, 0034 through 0041, 0045, 0047 through 0050, 0052, 0054, 0056 through 0059, 0064, 0067, 0071 through 0073, 0075 through 0080, 0082 through 0086, 0088 through 0095, 0097 through 0099, 0101 through 0105, 0107, 0108, 0110, 0111, 0113 through 0117, 0120-0123, 0125-0131, 0133-0135, 0137 through 0140, 0142 through 0165, 0167 through 0180, 0182 through 0191, 0194, 0195, 0197 through 0204, 0206, 0207, 0209, 0211 through 0235, 0237 through 0250, 0252 through 0291, 0293 through 0437, 0440 through 0522, 0524 through 0527, 0700 through 0725, 0727, 0730 through 0858, 0860 through 0878, 0880, 0881, 0885 through 0903, 0906 through 0912, 0922 and 0924.

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 #48576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.