Alerta De Seguridad para Advanced Perfusion System 1, Sarns Modular Perfusion System 8000, and Sarns Perfusion System 9000

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Terumo Cardiovascular Systems.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-08-26
  • Fecha de publicación del evento
    2013-08-26
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: terumo advanced perfusion system 1, sarns modular perfusion system 8000, and sarns perfusion system 9000 medical device manufacturer, terumo cardiovascular systems (cvs) corporation, has issued a field safety notice concerning lamp assembly of advanced perfusion system 1, sarns modular perfusion system 8000, and sarns perfusion system 9000. the affected catalogue numbers are 801558 (short neck lamp for terumo system 1); 801238 (long neck lamp for terumo system 1); 16420 (short neck lamp for sarns system 8000); 7278 (long neck lamp for sarns system 8000); and 144493 (positionable lamp assembly for sarns system 9000). a lamp available for use as an optional accessory with the terumo advanced perfusion system 1, sarns modular perfusion system 8000, and sarns perfusion system 9000 uses a halogen bulb which will become hot during use. there are no reported injuries as a result of this issue. however since 2007, six complaints have been received stating that plastic material or tubing have been melted, burned or deformed as a result of being placed very close to the halogen bulb or lamp housing. according to the manufacturer, heat generated from the halogen bulb in the lamp accessory can reach more than 90 degrees centigrade. this heat has the potential to melt, burn or ignite materials that may be placed in very close proximity to the bulb. heat damage to any component of the cardiopulmonary bypass circuit during a procedure would most likely require replacement of that component to complete the procedure. this could lead to an interruption of metabolic support for the patient. in addition, burn injury can occur to personnel that come in close contact with the hot lamp housing. terumo cvs is advising all users of the optional lamp accessory that it will become hot during use, and do not allow the lamp housing to touch the patient, user, perfusion circuit or other equipment during use. furthermore, terumo cvs will include the cautionary instructions in an addendum to the operator’s manual, which will be provided under separate cover. it will provide a label for the user to apply to the lamp that will contain the appropriate cautionary symbol for hot surface. this label also will be provided under separate cover. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 august 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Terumo Advanced Perfusion System 1, Sarns Modular Perfusion System 8000, and Sarns Perfusion System 9000
  • Manufacturer

Manufacturer