Events

Recall of Sams Modular Perfusion System 8000

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
    62733
  • Event Risk Class
    Class 2
  • Event Number
    Z-0281-2013
  • Event Date Posted
    2012-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111543
  • 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
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Reason
    Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular perfusion system 8000. the malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. if the malfunction of the arterial or cardio.
  • Action
    The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com. If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.

Device

Sams Modular Perfusion System 8000
  • Model / Serial
    catalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).
  • Product Description
    Perfusion System 8000, base 5 pump, 115V safety monitor included || The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • 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