Events

Recall of Device Recall Sarns 8000 Roller pump

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
    57241
  • Event Risk Class
    Class 2
  • Event Number
    Z-0562-2011
  • Event Initiated Date
    2010-11-02
  • Event Date Posted
    2010-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95647
  • 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 JOR
  • Reason
    The system 8000 roller pumps may fail resulting in a persistent pump stop.
  • Action
    The firm sent "URGENT MEDICAL DEVICE CORRECTION" dated 11/02/2010 to customers. The letter describes the product, problem and corrective actions taken and/or needed to be taken by the customers. The letter states the system responds to a failed inductor by displaying an overspeed message and stopping the roller pump without an audible alert. The pump cannot be restarted. The customers/users are instructed to stop the pump, replace the pump with a backup or if necessary use the handcrank. The letter states that Terumo will replace the roller pump at the next preventative maintenance visit - or sooner- if the customer has a service contract. If the customer does not have a service contract, Terumo will contact the customer within 2 weeks to set up an appointment for the service. Terumo CVS expects all affected inductors to be replaced to be replaced within three months. Call Terumo CVS Customer Service upon completion of the case at 800-521-2818. The customer was also instructed to complete and return the enclosed CUSTOMER RESPONSE FORM Please note that we are not recommending that you stop using the roller pumps for your Sarns system 8000. For any questions, call toll free 800-262-3304 or phone 734-663-4145.

Device

Device Recall Sarns 8000 Roller pump
  • Model / Serial
    lots 19945-19954 and 19985-20001.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • Product Description
    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No 16402, Terumo Cardiovascular System Corp Ann Arbor, MI. || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
  • 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