Events

Alerte De Sécurité sur Elongated One-Piece Arterial Cannula

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtronic.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-08-07
  • Date de publication de l'événement
    2015-08-07
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150807_a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medtronic elongated one-piece arterial arterial cannula medical device manufacturer, medtronic, has issued a medical device safety alert concerning its eopa (elongated one-piece arterial) arterial cannula [model number.: 77620; lot number: 2015060544]. the manufacturer is initiating an urgent medical device recall for 221 units of elongated one-piece arterial (eopa) arterial cannula that were shipped without the guidewire. product affected by this issue is limited to a single lot (2015060544) of model 77620. no other devices are affected by this recall. through 29 july 2015, the manufacturer has received two field reports of this issue with no reports of adverse patient effects. in both cases, the missing guidewire was noticed prior to use. further investigation has determined the guidewire is missing due to an isolated manufacturing error that has been addressed. the eopa arterial cannula is intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration. this cannula features a dilator tip introducer to facilitate cannula insertion and priming. the introducer features a guidewire port for use with a 0.038” guidewire. as indicated in the instructions for use (ifu) a guidewire must be used for proper placement of the introducer tip while inserting the cannula to avoid trauma to the back wall of the aorta. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 august 2015.

Device

Elongated One-Piece Arterial Cannula
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Elongated One-Piece Arterial Arterial Cannula
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH