—#50176

Product

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

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 0006 through 0066, 0100 through 0144, 0146, 0147 and 0149 may be affected by this issue. Serial number 0046 have been corrected to date.

Why it was recalled

System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.

Root cause (FDA determination)

Other

Action the firm took

The firm corrected the complaint units at the time of the complaints in 2005. The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that their system will be corrected when replacement components become available.

Recalling firm

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

Distribution

Distribution pattern: Worldwide: USA, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan and Singapore.

Timeline

Recall initiated: 2005-02-01
Posted by FDA: 2007-06-30
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50176. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.