Retiro De Equipo (Recall) de Device Recall Alaris Syringe Pump, Model No. 8110

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por CareFusion 303, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    71655
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2362-2015
  • Fecha de inicio del evento
    2015-07-21
  • Fecha de publicación del evento
    2015-08-14
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    Channel error code is displayed on the pc unit with an audio and visual alarm, and on the syringe module. after the error is cleared on the pcu, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
  • Acción
    An Urgent Medical Device Recall Notification letter was sent on 7/20/15 to customers who purchased the Alaris Syringe Module (Model 8110) to inform them that CareFusion has identified an issue with the Alaris Syringe module manufactured between March 2014 through September 2014. The letter informs customers of the problems identified and the actions to be taken. CareFusion will replace the syringe drive train assembly on the affected units and adjust, if required. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers are instructed to contact CareFusion Support Center (888-562-6018, 7am-4pm PT, M-F, supportcenter@carefusion.com) for recall related questions. Customers are instructed to contact Customer Advocacy (888-812-3266, 24hrs/day, 7days/wk, customerfeedback@carefusion.com) for adverse event reports. Customer are instructed to contact Technical Support (888-812-3229, 6am-5pm PT, M-F, dl-us-inf-techsupport@carefusion.com) for technical questions. Customers are instructed to complete and return the enclosed customer response card to expedite the corrective action process. A urgent recall letter for the expansion of the affected units was sent on 10/15/15 to inform customers of the expanded recall. The letter informs customers that the firm has identified an issue with the Alaris Syringe module model 8110 after receiving reports of customers experiencing an channel error on the Alaris Syringe module Model 8110. The letter informs customers that the recall is an expansion of affected units outlined in the CareFusion recall previously issued on 7/20/15. The letter provides the customers with the affected units, issue, potential risk, and actions to be taken. The corrective action for the expanded serial numbers will not change. The affected Alaris Syringe modules will be remediated with a hardware inspection and an adjustment, if required. CareFusion will contact all affected c

Device

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.
  • Descripción del producto
    Alaris Syringe Pump, Model No. 8110. Delivers fluids. || Expansion of Affected Units: || BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA