Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.
FDA Recall Z-2348-2012 · Posted 2012-09-11
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Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2009-08-12
Date Terminated2013-01-29
Product Quantity8
Reason for Recall
Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo
Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8
monitors were manufactured with an underrated circuit breaker due to an error where an associate
pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory
locations hav
Firm Action
TERUMO Cardiovascular Systems communicated with their affiliate, Terumo Dubai, in 2009 at the time the complaints were reported. No further communication was warranted.
For questions regarding this recall call 734-741-6173.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide distribution: International only-country of: Terumo Dubai, UAE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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