Events

Retiro De Equipo (Recall) de Device Recall Alaris Medley 8000,8100, 8110,8120,8210 and, 8220

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 Cardinal Health 303 Inc DBA Alaris Products.

¿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
    47335
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1711-2008
  • Fecha de inicio del evento
    2008-03-05
  • Fecha de publicación del evento
    2008-06-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69242
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    A channel error on an affected alaris system module will stop an active infusion (or monitoring) with an audible and visual alarm. channel errors with the alaris system due to the inter-unit interface (iui) connectors on all alaris system modules (manufactured on or before march 26, 2004). grey inter-unit interface connectors ("iui") on the following alaris system modules built on or before march.
  • Acción
    An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.

Device

Device Recall Alaris Medley 8000,8100, 8110,8120,8210 and, 8220
  • Modelo / Serial
    Pending
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WY, Guam and country of Canada. ****CDRH Comments: "Note for District Office to follow-up" The firm has not provided a grand total of devices affected by these problems. It is possible that devices suffering from U19 & U9 problems may also experience IUI problems. This recall has 3 problems with 6 modules. One problem affects only 2 modules, one problem affects 6 modules. For simplicity and expediency, CDRH agrees to keep the file as is, rather than separate into 6 products and have complicated explanations of the problems. 77,515 devices affected by IUI problem. 85,286 devices affected by U19 problem. 8,286 devices affected by U9 problem. ****
  • Descripción del producto
    Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit), || (2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module), || (3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module), || (4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module), || (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and || (6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology, CardinalHealth, San Diego, CA 92130
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • Dirección del fabricante
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA