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.
Publicado el 3 de octubre de 2012 · Inicio del retiro: 20 de septiembre de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Terumo Cardiovascular Systems Corporation
- Distribuidor
- Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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