Events

Retiro De Equipo (Recall) de Device Recall GemStar Docking Station

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
    67802
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1512-2014
  • Fecha de inicio del evento
    2014-02-18
  • Fecha de publicación del evento
    2014-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126354
  • 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
    There are two situations that may occur when using the gemstar docking station, list number 13075-xx-xx, in conjunction with the gemstar infusion pump: 1) when the docking station is used in conjunction with a gemstar phase 3 pump (list 13000-xx, 13100-xx, or 13150-xx) the potential exists for the gemstar phase 3 pump to fail to power up while connected to the docking station, and 2) when either a gemstar phase 3 (list 13000-xx, 13100-xx, or 13150-xx)or gemstar phase 4 pump (list 13086-xx, 13087-xx, or 13088-xx) is used in conjunction with both a docking station and an external battery pack accessory (list 13073-xx) there exists a possibility that the gemstar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. if the gemstar pump detects what is perceived to be more than 3.6 volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.
  • Acción
    Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included the following instructions: 1) To avoid failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power up. 2) To mitigate the potential for an 11/003 error code, remove the External Battery Pack accessory (List 13073) from the Docking Station in conjunction with an External Battery Pack accessory (List 13073), this practice should not continue. Please contact Hospira to discuss an appropriate alternative. Additional instructions included: 1) Inform potential users within the recipient's organization of the notification. 2) Should the facility experience a failure to power up or an 11/003 error code, report the issue to Hospira by calling 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CT) or e-mail ProductComplaintsPP@hospira.com. 3) Compelte the attached reply form and return it to the fax number or e-mail address on the firm, even if there is no affected product in inventory. 4) If th products were further distributed, notify the accounts that received the products identified in the notification and ask them to contact Steriycle at 866-792-5451 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. For questions regarding this recall call 800-441-4100.

Device

Device Recall GemStar Docking Station
  • Modelo / Serial
    *** US DOCKING STATIONS ***   List Numbers: 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09.   *** FOREIGN DOCKING STATIONS ***   List Numbers: 13075-24-01, 13075-24-03, 13075-24-05, 13075-24-07, 13075-92-09.
  • 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, 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, District of Columbia, Guam, Puerto Rico, and Internationally to Australia, Austria, Bahrain, Belgium, Canada, Chile, Egypt, France, Germany, Greece, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxemburg, Netherlands, New Zealand, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
  • 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