System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorpore

FDA device recall Z-2055-2012 · posted 2012-07-20 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application

Action taken

TERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, and an update to the Operator's Manual via Federal Express to inform consignees of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of backup system availability. Consignees were instructed to review the Medical Device Correction notice, assure that all users are aware of the notice. Place the Addendum at the beginning of the Centrifugal System Section of the Operator's Manual, Confirm receipt of the communication by faxing or emailing a completed Customer Response Form as indicated on the form. For any questions customers should call 1-800-521-2818.

Root cause

Equipment maintenance

Status

Terminated

Product code

DTQ

Quantity affected

992 devices

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Hondura

Date initiated

2012-06-22

Date posted

2012-07-20

Date terminated

2013-03-06

Location

Ann Arbor, MI

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