Events

Rappel de Device Recall GemStar

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Hospira Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68200
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2031-2014
  • Date de mise en oeuvre de l'événement
    2014-01-31
  • Date de publication de l'événement
    2014-07-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127209
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    The connection between the beeper subassembly and the pump may fail. the gemstar infusion pump will identify this failure during the "self-test" while powering up which will result in a beeper error ("code 10/001/000"). this beeper error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
  • Action
    Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 31, 2014 was sent to all affected customers. The letter included instructions for customers to: 1) inform potential users of these devices of the notification, 2) if the beeper error occurs during power up, remove the device from service immediately, 3) report any beeper errors to Hospira by calling 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or e-mail ProductComplaintsPP@hospira.com, 4) complete the attached reply form and return it to the fax number of e-mail address on the form (even if there is no product in inventory), and 5) if the products were further distributed, notify those customers that received the products and ask them to contact Stericycle at 855-827-6578 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. A subsequent letter was sent on February 18, 2014 that included a correction to the description of the error code generated when a beeper wire failure occurs. That letter included identical instructions as those found in the January 31, 2014 letter for recipients to follow.

Device

Device Recall GemStar
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US: Nationwide in the state of 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 including District Of Columbia, Guam, Puerto Rico; and the countries of Austria, Australia, Bahrain, Belgium, Canada, Chile, France, Germany, Greece, Guatemala, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Netherlands, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela
  • Description du dispositif
    GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA