134332 Sarns centrifugal cable to System 8000 1 135271 Operator's manual 1. Sarns™ Modular Perfusion System 8000 Sarns Modular Perfusion System 8000 Catalog Number Description Units/Case Base 16400 Base, 4 pump, 115V, safety monitor included 1. Consoles have been maintained in patient ready condition and is ready to ship to qualified buyer. Yamaha Outboard Motor 70 Hp Owners Manual there. Browse these categories under 'Hardware & Software' Featured products under 'Hardware & Software' Sort by: Price $25,000.00 List Price: $95,000.00 You Save: $70,000.00 (74%) This item is an Abiomed VAD model AB5000 console that has never been lightly used clinically. We offer factory certified repair services on almost all equipment that we sell. If you do not find what you are looking for here or if you are interested in selling your equipment, please us for an estimate. Offers a variety of high quality, new and pre-owned extracorporeal hardware for sale or lease.
SARNS 8000 MANUAL CODE
Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.› 〓〓 Sarns 8000 Manual 〓〓 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. 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).ġ A record in this database is created when a firm initiates a correction or removal action. 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: 1-73 or email to:If you have any questions or concerns contact Terumo CVS Customer Service at 1-80 Monday - Friday, 8 AM - 6 PM ET. The notice described the product, problem and actions to be taken.
The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated Septemand an addendum to the Operator's Manual to alert all affected Customers. If the malfunction of the arterial or cardio The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular
Terumo Cardiovascular Systems Corporation
SARNS 8000 MANUAL SERIAL
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.Ĭatalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003. Perfusion System 8000, base 5 pump, 115V safety monitor included Class 2 Device Recall Sams Modular Perfusion System 8000Ĭonsole, heart-lung machine, cardiopulmonary bypass - Product Code DTQ