Events

Retiro De Equipo (Recall) de Device Recall CDI 500 Monitor

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 Terumo Cardiovascular Systems Corporation.

¿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
    60480
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1732-2013
  • Fecha de inicio del evento
    2013-02-27
  • Fecha de publicación del evento
    2013-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109151
  • 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
    Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
  • Causa
    Terumo discovered through its own testing that cdi 500 blood parameter monitoring system software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for hematocrit/saturation calculations.
  • Acción
    On 2/27/13, all consignees will receive a recall notification letter via Federal Express. Terumo CVS will correct all affected CDl Monitors. Correction to the devices will be completed concurrently with BPM replacements related to Z-2185/2189-11 RES 57194. Terumo continues to manufacture and ship devices affected by this recall. The long term corrective actions are associated with Recall# Z-2185/2189-11 RES 57194. As committed previously, we will re-notify all customers once we are ready to implement the fix for the BPM in the field. All units produced prior to the change in manufacturing will be included in the scope of this correction. Terumo continues to manufacturer units affected by this correction. All units returned for this correction will be tagged with a service traveler to indicate reason for correction and units will be properly segregated to prevent unintended re-shipment.

Device

Device Recall CDI 500 Monitor
  • Modelo / Serial
    Catalog number: 500AV* and serial numbers: 0024, 0033, 0040, 0051, 1192, 1193, 1355,1356, 1420, 1423, 1464, 1465, 1467, 1468,1483,1504,1521-1524,1526,1527,1529,1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901,2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, 5578, and 5579.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
  • Descripción del producto
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. || Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA