Events

Rappel de Power cord used on BioConsole, autoLog, Sequestra

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 Medtronic Cardiovascular Revascularization & Surgical Therap.

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
    55749
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1939-2010
  • Date de mise en oeuvre de l'événement
    2010-04-21
  • Date de publication de l'événement
    2010-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91714
  • 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
    power cord on cardiopulmonary bypass - Product Code DWA
  • Cause
    The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. although medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. this field notificatio.
  • Action
    Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.

Device

Power cord used on BioConsole, autoLog, Sequestra
  • Modèle / numéro de série
    Part # 66319 & 055476
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
  • Description du dispositif
    Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: || Medtronic Bio-Console¿ 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. || Medtronic Bio-Console¿ 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. || Medtronic autoLog¿, Model # ATLG110, Catalogue # ATLG110, ATLG110E || ATLG110R. || Medtronic Sequestra¿ 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
  • Manufacturer
    Medtronic Cardiovascular Revascularization & Surgical Therap

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • Adresse du fabricant
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA