Events

Retiro De Equipo (Recall) de Device Recall Medfusion Syringe Pump

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 Smiths Medical ASD 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
    78922
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1134-2018
  • Fecha de inicio del evento
    2017-11-13
  • Fecha de publicación del evento
    2018-03-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160911
  • 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
    Certain medfusion syringe pump models, series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. the inability of a pump to recognize a syringe (i.E. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. misidentification of a syringe is where the pump misinterprets the syringe size.
  • Acción
    Consignees were notified via mail on 11/13/2017, 01/09/2018, and 02/12/2018, as a result of expansions of the recall and the need to provide additional instructions and information to consignees. Instructions in the first letter date 11/13/2017 instructed customers to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to utilize the enclosed Reference Tool when verifying syringe size, and to complete the return the Response Form. Instructions in the letter dated 01/09/2018 included to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to advise all clinicians overseeing use of the affected devices to utilize the enclosed Reference Tool, to remove the pump if the syringe is not recognized or is read as an incorrect size during programming or infusion, to notify impacted customers if the devices were further distributed, and to complete the return the Response Form. Instructions in the letters dated 02/12/2018 included to identify any affected devices on hand, complete and return the Urgent Medical Device Recall Response Form, and arrange for repair of the affected as per the location of the consignee in Canada or the USA. If the consignee is located in the USA, the three options include to return to Smiths Medical for repair, arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair, or arrange for onsite repair by Smiths Medical if there are more than 10 pumps onsite. If the consignee is located in Canada, the two options include to return to Smiths Medical for repair or arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair. Consignees not located in the USA or Canada were instructed to contact their Smiths Medical Representative to discuss repair options. For further questions, please send inquiries to SmithsMedical3033@stericycle.com.

Device

Device Recall Medfusion Syringe Pump
  • Modelo / Serial
    Product Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Medfusion Syringe Pump 4000 Series || The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Dirección del fabricante
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA