Events

Rappel de Medtronic Pressure Display Box

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 Perfusion Systems.

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
    59948
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0077-2012
  • Date de mise en oeuvre de l'événement
    2011-09-09
  • Date de publication de l'événement
    2011-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104063
  • 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
    Gauge, pressure, coronary, cardiopulmonary bypass - Product Code DXS
  • Cause
    The dfu for the medtronic pressure display box, model 66000, states that, for display readings of -100 to +300 mmhg there will be an accuracy of +/-5 mmhg, and for display readings of +301 to +500 mmhg there will be an accuracy of +/-10 mmhg. through reports from customers, medtronic has become aware that the pressure display box may not always accurately display readings. during use in the -40.
  • Action
    Medtronic Perfusion Systems, sent an "Urgent Medical Device Notification letter dated September 9, 2011, via UPS 2-day delivery to all affected customers. The letter identified the affected devices, described the issues, and the actions needed to be taken. The letter indicates when approved, the updated Directions for Use for the Pressure Display Box and Pressure Display Sets will be sent to customers. Customers were asked to complete the Customer Confirmation Certificate and return to Medtronic per the instructions on the form. The letter states that if the recalled products have been further distributed, forward this letter immediately to all customers who received the affected products, and gather proof of notification. For further questions concerning this notification, contact Medtronic Cardiovascular Technical Support at 877-526-7890 or Medtronic Sales Representative.

Device

Medtronic Pressure Display Box
  • Modèle / numéro de série
    serial numbers: 301010, 301012, 301013, 301015, 301016, 301017, 301018, 301019, 301020, 301023, 301024, 301025, 301026, 301027, 301029 thru 301041, 301043 thru 301050, 301052, 301053, 301054, 301055, 301056, 301057, 301058, 301060, 301061, 301062, 301063, 301068 thru 301085, 301087, 301088, 301090, 301091, 301092, 301093, 301094, 301300, 301301, 301302, 301303, 301371 thru 301383, 301385, 301387, 301388, 301389, 301390, 301394, 301396, 301397, 301399 thru 301407, 301409, 301410, 301431 thru 301450, 301460, 301461, 301462, 301464, 301467 thru 301485, 301487 thru 301507, 301509 thru 301526, 301560 thru 301663, 301665 thru 301704, 301707 thru 301751, 301753, 301754, 301755, 301756, 301758 thru 301817, 301819 thru 301842, 301844 thru 302148, 302150 thru 302161,   PDBR400000 thru PDBR400127, PDBR400129 thru PDBR400835, PDBR400847 thru PDBR401104, PDBR401107 thru PDBR401178.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.
  • Description du dispositif
    Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The alarm will be activated when the pressure is equal to or beyond the set value. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55431-5604. || Product Usage: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Adresse du fabricant
    Medtronic Perfusion Systems, 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