Events

Retiro De Equipo (Recall) de Device Recall MicroStream Filterline ICU

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Oridion Medical 1987 Ltd..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58373
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2236-2011
  • Fecha de inicio del evento
    2011-03-25
  • Fecha de publicación del evento
    2011-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99312
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    Fine plastic strands on inner surface of the infant neonatal airway adapter may become dislodged and inhaled by the patient.
  • Acción
    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
  • Modelo / Serial
    Lot Numbers: M8535B11 M8573B11
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution.
  • Descripción del producto
    Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (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.
  • Dirección del fabricante
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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