—#48589

Product

Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.

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 00010 through 00016, 00019, 00024 through 00027, 00030 through 00033, 00035, 00036, 00038 through 00040, 00042 through 00046, 00048 through 00050, 00052 through 00054, 00056 through 00059, 00061 through 00063, 00065, 00066, 00068, 00069, 00071 through 00073, 00075 through 00078, 00082, 00084, 00085, 00087, 00088, 00091, 00094, 00095, 00098 through 00103, 00105 through 00107, 00109 through 00111, 00113 through 00115, 00122, 00126 through 00129, 00133 through 00135, 00139, 00140, 00144, 00145, 00147, 00148, 00151, 00152, 00154 through 00157, 00163, 00167, 00168 through 00174, 00176 through 00182, 00184 through 00196, 00200, 00202 through 00206, 00210, 00211, 00213, 00214, 00216 through 00224, 00228 through 00231, 00237 through 00241, 00245 through 00250, 00300 through 00327 and 00330.

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 #48589. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.