PERFUSION REPORTS

REPORT
007
DATE
1/5/2011
TITLE
Deficiencies In The QC At Terumo Ann Arbor, USA.
DETAILS OF INCIDENT

Terumo Cardiovascular Systems has entered into a consent decree agreement with the US Food and Drug Administration (FDA) to address concerns the FDA have with the deficiencies in the Quality Systems at the Terumo CVS manufacturing facility in Ann Arbor, USA.

DETAILS OF INJURY TO PATIENT
TYPE OF DEVICE/MANUFACTURER
ACTION TAKEN

The Safety Committee recognises that there are no safety related issues at this time but we want to make the UK community aware of this situation. We will continue to monitor events and report further developments as necessary. Current users of Terumo products, produced at the Ann Arbor plant, will have already signed the relevant paperwork to continue using those products.

RESPONSE FROM MANUFACTURER
ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

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Detached bullet tip of sump-updated response Sep 2022
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