—#188471

Product

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K172220
Affected lot / code info: S/N: 01751 UDI: 00886799000588

Why it was recalled

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Terumo notified the regional affiliate to address the single EPGS device in Panama via email on 6/8/21. Letter states reason for recall, health risk and action to take: Terumo CVS will execute a field correction to replace the one (1) affected EPGS device. A Terumo Representative will contact you to schedule the field correction activities. 1. Review this Medical Device Correction and assure the user has received notice of this issue. 2. A Terumo representative will contact the user to schedule the field correction activity. Note: Terumo CVS recommends that users continue using the affected Terumo System 1 while waiting for this correction. We encourage you to contact your local Terumo representative with any questions or concerns.

Recalling firm

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

Distribution

Distribution pattern: International distribution in the country of Panama.

Timeline

Recall initiated: 2021-06-08
Terminated: 2022-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.