Events

Rappel de Device Recall MicroStream Filterline ICU

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 Oridion Medical 1987 Ltd..

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
    58373
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2234-2011
  • Date de mise en oeuvre de l'événement
    2011-03-25
  • Date de publication de l'événement
    2011-05-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99310
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    Fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient.
  • Action
    The firm, Oridion, sent an "Microstream Filterline Field Correction Notice" letter dated March 25, 2011 to its US and foreign customers via telephone, email with the documentation discussed in the call, and letter. The letter described the product, problem and actions to be taken. The customers were instructed to place all affected product held in their inventory on ship hold; gather these units in their inventory and at the customer sites and exchange with the new product; inspect filter line starter (sample) kits shipped with Capnostream 20 and Microcap patient monitors for affected product, if affected Infant/Neonatal filter lines are found, remove them from the starter (sample) kit; send a purchase order in order to obtain replacement product for units in their stock and at customers sites, and complete and return the Inventory Reporting Form Excel Spread Sheet within two weeks of receiving the email even if they or their customers do not have the affected inventory. Oridion shall conduct a removal of the products from the related production lots from the field and an immediate replacement with product from subsequent production lots that meet all requirements. This action will be conducted by Oridion's distributors or by Oridion directly in some cases. Oridion anticipates that new product will be available for shipment during the week of April 4th. Questions regarding the recall can be directed towards the Customer Service Coordinator at: 1-888-674-3466 x1234 or NA-FCA@oridion.com.

Device

Device Recall MicroStream Filterline ICU
  • Modèle / numéro de série
    Lot Numbers: M8286M10 M8300M10 M8406P10 M8544B11 M8555B11 M8575B11
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
  • Manufacturer
    Oridion Medical 1987 Ltd.

Manufacturer

Oridion Medical 1987 Ltd.
  • Adresse du fabricant
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • 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