device · product 1 of 1
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
- Recall number
- Z-2449-2012
- Initiated
- September 20, 2012
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 72 units
App-derived interpretation
Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a populat
Code information
Catalog number: 802018 and serial numbers: 00122,00132, 00137, 00321-00337, 00339, 00340, 00342-00389,00391-00439, 00441, 00442, 00444-00455, 00457, 00459, 00460, 00466, 00467, 00475, and 00488.
Distribution pattern
Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.