Sarns 8000 Manual

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Sarns 8000 Manual Online

Sarns 8000 Manual

The Terumo Sarns Modular Perfusion System 8000 is a flexible, dependable, and cost efficient modular blood pumping system.The Sarns 8000 is a modular heart-lung machine that is available in a variety of configurations. We offer 4 and 5 pumps units that are available with and without the built-in centrifugal pump. I have a Charcoal Grill. Locate your Model Number. The model number of most Char-Broil charcoal grills can be found on a small white label on one of the legs of the grill. Oklahoma Joe's charcoal grills may have a serial number on a plate attached to the lid of the grill. Char-Broil charcoal Model Number Location (back of bottom shelf). TM Temperature Control Monitor Sarns TCM II Why choose the TCM II? The powerful SarnsTM TCM II provides the precise temperature control you need to monitor patients on cardiopulmonary bypass. Its sensitive, microprocessor-driven system lets you cool, rewarm or maintain temperatures at exact levels with the push of a button. Sarns centrifugal cable to System 8000 134332 SarnsTM Centrifugal System Control module, 100/115V 6379 Control module, 220/240V 6380 Non-invasive ﬂow sensor 3/8” x 3/32” ID 6382 (9.5 mm x 2.4mm) wall, reusable Drive motor 164267 Flexible mounting arm 816620 Manual drive unit 164268 Battery, 100/115V 9490 Includes charger and connecting cable.

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Class 2 Device Recall Sams Modular Perfusion System 8000

Z-0282-2013
Date Initiated by Firm	September 25, 2012
Date Posted	November 13, 2012
Recall Status¹	Terminated ³ on July 11, 2013
Recall Event ID	62733
K915183
Console, heart-lung machine, cardiopulmonary bypass - Product CodeDTQ
Product	Perfusion System 8000, base 4 pump, 220V/240V 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.
Code Information	catalog number: 16405 serial numbers: 1001-1466.
Recalling Firm/ Manufacturer	Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
For Additional Information Contact	734-741-6173
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
Device Design
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.
466
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).
TPLC Device Report
¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. ² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. ³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database	510(K)s with Product Code = DTQ and Original Applicant = 3M HEALTH CARE, SARNS