Events

Rappel de Device Recall Master Drug Library to be used with SIGMA Spectrum Infusion Pump

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 Baxter Healthcare Corp.

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
    70658
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1451-2015
  • Date de mise en oeuvre de l'événement
    2015-03-02
  • Date de publication de l'événement
    2015-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134355
  • 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.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    Loading/bolus default dose settings in the master drug library and the values shown on the pump during programming may differ. mdl drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). the pump will administer drugs as configured. the discrepancy may cause therapy delay or unintended rate of delivery.
  • Action
    The firm, Baxter, sent an "Urgent Device Correction" letter dated 3/05/2015 with MDL Instructions were sent to all affected users via USPS First Class Mail on 3/05/2015. All four (4) limited launch locations with Master Drug Library (MDL) version 8.0 with SIGMA Spectrum Infusion System version 8.0 were notified via phone call on 3/02/2015. The letter describes the product, problem and actions to be taken. Baxter is requesting customers take the following actions: 1. Follow the steps described in Attachment 1 to confirm that this discrepancy is properly corrected. 2. Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. --- Baxter sent a follow-up Communication Letter (dated 3/17/2015) to the initial Urgent Device Correction Letter (dated 3/5/2015) to provide additional clarification and instructions to ensure continued mitigation of this discrepancy as users implement the Spectrum infusion System in their facility. The four launch sites received the follow-up letters via hand delivery; remaining customers received the follow-up letter via hand delivery and/or e-mail. If you have additional questions, please contact your Baxter sales representative, Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, during the hours of 7:00 am to 7:00 pm Eastern Time, or The Center for One Baxter at 800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

Device

Device Recall Master Drug Library to be used with SIGMA Spectrum Infusion Pump
  • Modèle / numéro de série
    Software version 8.0, Product Code 35723V080
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
  • Description du dispositif
    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 || The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • Adresse du fabricant
    Baxter Healthcare Corp, 1 Baxter Pkwy # Df6-3w, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA