Events

Recall of Sarns Modular Perfusion System 8000, Circuit Board for MBattery Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59479
  • Event Risk Class
    Class 2
  • Event Number
    Z-0303-2012
  • Event Initiated Date
    2011-10-21
  • Event Date Posted
    2011-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102865
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, blood, cardiopulmonary bypass, roller type - Product Code DWB
  • Reason
    Terumo cardiovascular systems is aware on one instance in which an incorrectly labeled printed circuit board for the sarns modular perfusion system 8000 was shipped to a single customer. the affected board mislabeled two connection between the board and the transformer.
  • Action
    Terumo conducted a Correction/Removal - Customer Communicated Script on November 7, 2011 to the affected customer. The phone script communicated the correction and reason for removal, potential hazards, affected population, and confirmation of possession of affected module. A replacement date was set for November 7, 2011. For questions or concerns contact Terumo CVS Customer Service at 1-800-521-2818, hours are Monday to Friday. 8 AM -6 PM EST.

Device

Sarns Modular Perfusion System 8000, Circuit Board for MBattery Module
  • Model / Serial
    Catalog Number 16422 Serial Number 1901
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the state of San Antonio, TX
  • Product Description
    Battery Module for Sarns Modular Perfusion System 8000 || Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA