Events

Retiro De Equipo (Recall) de Device Recall Gemstar Infusion System

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 Hospira 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
    64832
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0350-2014
  • Fecha de inicio del evento
    2013-03-15
  • Fecha de publicación del evento
    2013-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117221
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    The proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test, as described in the gemstar technical service manual, or reporting one of the following errors during device setup or infusion: 1) cassette check - d; 2) cassette check - p; 3) proximal occlusion; 4) distal occlusion; 5) pressure calibration error; 6) bad pressure sensor event; 7) bad pressure state; 8) distal pressure is out of range; 9) proximal sensor is out of range. a pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
  • Acción
    Hospira sent an Urgent Device Field Correction letter dated March 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter asks that customers immediately perform proximal and distal occlusion tests as defined i nthe GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service and contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM) to report the issue and arrange for the return of the device for recalibration. The letter further reminds customers that the proximal and distal occlusion tests should be performed on an annual basis as a part of the yearly GemStar maintenance schedule. Customers were also requested to complete and return the attached reply form and return it to Hospira by fax to 1-888-714-5077 or by e-mail to Hospira7906@stericycle.com. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. For questions regarding this recall call 800-441-4100.

Device

Device Recall Gemstar Infusion System
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
  • Descripción del producto
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA