![]() ![]() Therefore, when visual discrimination is not appropriate, venous puncture must be confirmed using pressure waveforms. However, these findings may be unreliable depending on oxygen saturation, systemic blood pressure, and tricuspid regurgitation. ![]() In most cases of CVC, one can differentiate a successful venous puncture from an arterial puncture based on the color and pulsation of regurgitated blood flow. In contrast, arterial puncture, the most frequent complication of CVC, is associated more with an internal jugular approach than with a subclavian approach, the incidence of which is reportedly 3-9%. Among the various approaches possible for CVC, the internal jugular vein is the most preferred site because it has certain advantages including easier catheterization, resultant high rate of success when using only anatomical landmarks of the sternocleidomastoid muscle (SCM), and a straighter path to the superior vena cava compared to that of the subclavian vein, resulting in a fewer incidence of malpositioning and more precise measurement of central venous pressure. To prevent arterial catheterization, one should limit the leftward rotation of the head by <40° and consider using ultrasound-guided method after more than two unsuccessful attempts.Ĭentral venous catheterization (CVC) is a standard anesthetic procedure for cardiovascular medications, volume status monitoring, and rapid infusion of fluids and blood products. ![]() When visual discrimination between arterial and venous blood regurgitation is unreliable, anesthesiologists should confirm that using all the available methods one has on the scene, especially after at least two unsuccessful attempts or in patients with advanced age or clinical conditions resulting in jugular venous dilation. The pressure waveforms, however, abruptly changed from a venous to an arterial waveform during surgery. Central venous pressure measurement was initially 20 mmHg in supine, and then elevated to 30-40 mmHg in right lateral decubitus, presumably resulting from constrictive physiology of pericarditis. This record will be updated as the status changes.We present a case of inadvertent arterial insertion of a central venous catheter, identified during a pericardiectomy procedure after observing abrupt changes in pressure waveform and confirmed via arterial blood gas analysis and transesophageal echocardiography. 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 The manufacturer has initiated the recall and not all products have been corrected or removed. 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. Nationwide distribution in the states of MD, MI, OH, and TX.ġ A record in this database is created when a firm initiates a correction or removal action. ![]() If customer have any questions concerning this communication, contact Merit Sales Representative or Merit Customer Service at (801) 208-4381 | Hours: 6 am to 6 pm MST | Mon-Fri. Immediately return all affected lots in their possession to Merit, per the instructions in the attached CRF. All affected product shipped to customers must be accounted for on the CRF.ĥ. Fill out, scan and email the completed Customer Response Form to Customer Service at within seven (7) days. Additional distribution details may be required by health authorities.Ĥ. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Ensure that applicable personnel within their organization are made aware of this field action.ģ. Immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution.Ģ. is voluntarily conducting a recall of the Flex-Neck¿ Catheter External Repair Kit due to an internal system error that inadvertently allowed an engineering configuration to be released for distribution to customers.ġ. On, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" via email to customers informing them that, Merit Medical Systems, Inc. Software Manufacturing/Software Deployment Product that was built for design verification testing was inadvertently distributed to customers. Class 2 Device Recall FlexNeck Catheter External Repair KitĬatheter, peritoneal, long-term indwelling - Product Code FJSįlex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A ![]()
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