Events

Retiro De Equipo (Recall) de Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit

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 Pulsion Medical Inc.

¿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
    69782
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1121-2015
  • Fecha de inicio del evento
    2014-11-04
  • Fecha de publicación del evento
    2015-02-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131534
  • 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
    Probe, thermodilution - Product Code KRB
  • Causa
    Internal testing and investigation of the packaging revealed cracks and holes in primary packaging.
  • Acción
    Pulsion sent an Urgent Medical Device Recall notification letter on 11/04/14 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers where instructed to: " Piease examine your inventory immediately to determine if you have any of the products listed. " lf so, please remove the affected products; quarantine them in a secure location. " Piease complete and return the enclosed Field Recall Response Form, acknowleding your receipt and understanding of this communication " Send all affected products back to PULSION Medical Systems. " Upon return of the affected product you will receive a credit note. For questions contact your PULSION Medical lnc Recall Coordinator.

Device

Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit
  • Modelo / Serial
    Model Number PV8810US; Lot # 14AK20 and 14EK20
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
  • Descripción del producto
    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. || Product Usage: || Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
  • Manufacturer
    Pulsion Medical Inc

Manufacturer

Pulsion Medical Inc
  • Dirección del fabricante
    Pulsion Medical Inc, 3781 Attucks Dr, Powell OH 43065-6080
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA