The yellow diamond alarm indicates low external battery power. The heartmate ii lvadheartware hvad function is sensitive to changes in blood. Aug 10, 2016 a brief introduction to the most common audio alarms ems may encounter with the heartmate ii lvad controller. Thoratec heartmate ii pocket controllers linked to four deaths march 5, 2014 written by. The michael brady lynch firm offers case evaluations at no cost or obligation to you. Mar 05, 2014 thoratec heartmate ii pocket controllers linked to four deaths march 5, 2014 written by. Heartmate 3 pocket controller guide controller key functions and alarms. On march 29, 2017, abbott laboratories issued a product alert affecting 28,882 heartmate ii controllers worldwide, after receiving at least 70 reports of the devices malfunctioning while patients attempted to change the battery controller at home. Food and drug administration fda to market the heartmate ii pocket controller, the small, smart, safe face of the heartmate ii lvad system. Our life depends on a machine, protecting this machine is a primary concern and stress. Heartmate ii left ventricular assist system lvas by.
Thoratec has announced that four patients have died and at least five. Look at the lights next to the charging pocket for the battery. May 24, 2017 home deaths prompt abbott recall of thoratec heartmate ii controllers. A backup system controller is provided to each patient in the event of a device alarm or malfunction.
To address this issue, abbottthoratec is providing all heartmate ii lvas with pocket controller users with new software and hardware updates to assist patients in successfully changing their. Heartmate ii lvas pocket system controller recall following. The pocket system controller is a power supply that connects to the implanted heartmate ii lvas pump through a. When the pm is plugged into an electrical outlet, it provides ac electrical power to the system. Of the reported cases, 26 resulted in patient death and 19 involved serious. Patients should contact their centers to learn more about the heartmate ii system and the new pocket controller.
Heartmate ii lvad is indicated for patients in nyha class iiib and iv, and is clinically proven for both short and longterm support. Thoratec heartmate ii pocket controller recall issued. The heartmate ii lvas system is a left ventricle assist system that aids in the circulation of blood when the heart is too week to adequately pump on its own. Heartmate ineedhelp patient referral triggers pocket card. Backup battery provides at least 15 minutes of full power in an emergency situation. The heartmate ii lvas pocket system controller is intended for use inside or outside of the hospital. Thoratec heartmate ii instructions for use manual pdf download. The fda issued a class i recall against heartmate ii left ventricle assist lvas pocket system controller manufacturer, abbottthoratec. Thoratec corporation lvad recall gets class i status biospace. Thoratec issues urgent labeling correction for heartmate ii. Thoratec heartmate ii pocket controller recall issued after. The heartmate ii lvas pocket system controller is an external power supply that connects to the heartmate ii lvas pump, an implanted device, through a lead under the skin. Flexibility to treat more patients external pocket controller controls the lvad, and is small and light enough to fit in a pocket wearable external batteries two rechargeable 1pound batteries deliver up to 12.
Jul 19, 20 july 19, 20 the mount sinai medical center is the first medical center in new york city to offer the heartmate ii pocket controller, newly approved by the u. It is either in the seam or the little pocket next to the battery depending on your size. Abt recalled its heartmate ii lvas pocket system controller due to risk of patient injury andor death during backup controller exchange. The controllers monitor the heartmate ii and warn patients if the battery charge is running low. Place the controller in the pocket, securing it with the vertical strap first and then the horizontal strap going over and then under the cords. Fda recalls around 30,000 abbottthoratecs heartmate ii. The company released a new version of the pocket controller in august 2012 in europe, and then in. Thoratec offers added info regarding heartmate ii lvas. Thoratec issues urgent labeling correction for heartmate.
Thoratec heartmate ii lawsuit lvad device failure death. Clearance may 17th, 20 medgadget editors cardiac surgery, cardiology thoratec received fda clearance to offer its pocket controller for. Abbott abt recalls heartmate ii lvas pocket system. The heartmate ii left ventricular assist system lvas is designed to provide years of. Pocket controller and you received your device more than two years ago, please contact your doctor immediately to have the expiration date of the backup battery within your heartmate ii system controllers both. This latest generation controller for the heartmate ii left ventricular assist device lvad is a new small, lightweight, patientfriendly external controller about the size. Designed to dramatically improve survival and quality of life, the heartmate ii was developed with the goal of providing circulatory support for a broad range of advanced heart failure patients. Heartmate 3 tm guide to replacing the running system controller with the backup controller for clinicians. Thoratec corporation announces fda approval of heartmate. Pocket system controller will not communicate with system monitor. This pocket controller can help new patients and the more than 6,000 patients currently on heartmate ii support. The controller is powered by batteries or connected to a main power supply. Heartmate 3 pocket controller flashing yellow diamond alarm what is a flashing yellow diamond alarm.
Injuries and deaths linked to heartmate ii lvas pocket system controller. Patientfamily education teaching protocol heartmate ii left. Bosco lvad vest mobility restored for lvad patients. Heartmate ii left ventricular assist device lvad abbott.
Prioritized visual alarms provide clear, actionable instructions. Class 1 recall of heartmate ii lvas pocket system controller. This latestgeneration controller for the heartmate ii left ventricular assist device lvad is a new small, lightweight, patientfriendly external controller about the size of a smart phone. These products are intended for use by or under the direction of a physician. Heartmate ii 3 system components hmii pocket controller power module mpu mobile power unit battery charger and batteries hm3 pocket controller. The heartmate ii is a left ventricular assist device lvad. Food and drug administration fda, to help its advanced heart failure patients maintain more active lifestyles. Mar 18, 2014 patients who were 1st given an older heartmate ii controller who then switched to the pocket version are at a higher risk of experiencing difficulty in the controller exchange process, thoratec. Thoratec offers added info regarding heartmate ii lvas pocket. The pocket controller is lighter and more compact than previous lvad system. Thoratec updates heartmate ii controller warning massdevice. Heartmate ii left ventricular assist system instructions for use iii. Heartmate 3 pocket controller flashing yellow diamond alarm.
Heartmate 3 tm mobile power unit alarms for clinicians. Class 1 device recall heartmate ii left ventricular assist. The mount sinai medical center first in new york city to. Apr 02, 2014 thoratec heartmate ii pocket controller recall issued after deaths april 2, 2014 written by. The pocket system controller is a power supply that connects to the implanted heartmate ii lvas pump through a lead driveline under the skin. Thoratec corporation issues worldwide urgent medical. Apr 12, 2017 heartmate 2 3 pocket controller change. Thoratec heartmate ii pocket controllers linked to four. Prior to use, reference the instructions for use, inside the product carton when available or online for more detailed information on indications, contraindications, warnings, precautions and adverse events. Illustrations are artists representations only and should not be considered as engineering. Thoratec corporation lvad recall gets class i status. Heartmate ii the heartmate ii is surgically implanted just below the diaphragm in the abdomen. The heartmate ii left ventricular assist system is indicated for use as a bridge to transplantation for cardiac transplant candidates who are at risk of imminent death from nonreversible left ventricle failure. The users had experienced problems with the external controller for the heartmate ii left ventricular assist system, a pump inside the body that helps the.
Sep 17, 2015 if you are a heartmate ii lvas patient and the serial number on your system controller starts with the letters pc i. Mount sinai medical center first in new york to offer. Abbottthoratecs heartmate ii left ventricle assist lvas pocket system controller has been the center of multiple recalls since the device injured thousands of people. In offering heartmate ii lvad patients our nextgeneration pocket controller device, we are providing a product that has been extensively tested and is designed for greater ease of. Prioritized visual alarms with clear, actionable instructions. Patients with the heartmate ii have a 2 year survival rate 7xs greater than medical therapy alone 58% slide 12 bridge to transplant. The heartmate ii is abbotts firstline intermediatetochronic left ventricular assist device. Heartmate ii lvas instructions for use featuring the mobile. Mar 06, 2014 thoratec warns of heart pumps link to 4 patient deaths thoratecs stock drops after warning about heartmate ii.
As of february 4, 2014, thoratec has received four 4 reports 0. Thoratec received fda clearance to offer its pocket controller for patients using the companys heartmate ii lvad left ventricular assist device. The heartmate ii left ventricular assist system duration. Keeping it inside your clothes is a great way to hide and protect it.
Having that controller secure so it never gets bumped hard or falls, is something we constantly worry about. To find an implant center near you, please visit about heartmate ii heartmate ii is the most widely used and extensively studied lvad in the world. For outside battery pockets, find the hole for the cord to exit the vest. Pocket controller and you received your device more than two years ago, please contact your doctor immediately to have the expiration date of the backup battery within your heartmate ii system controllers both primary. Patients are at risk of problems when exchanging an older controller for the pocket controller. Patientfamily education teaching protocol heartmate ii. The fda has determined that a warning issued by last month by thoratec. Fda approval of heartmate ii pocket controller todays. Jude medical is providing all users of their heartmate ii lvas with pocket controller with new software and updates to hardware to make the exchange to a backup controller easier. The pocket controller has been prescribed for 2,142 patients either at the time of the implantation of the heartmate ii lvad, or as a replacement for an older system controller model. The heartmate ii left ventricular assist system is intended for use both inside and outside of the hospital, or for transportation of left ventricular assist device patients via ground ambulance, airplane, or. Thoratec announces fda approval of heartmate ii pocket. Deaths prompt abbott recall of thoratec heartmate ii controllers. Thoratec warns of heart pumps link to 4 patient deaths.
Abbottthoratecs heartmate ii left ventricle assist lvas pocket system controller has been the center of multiple recalls since the device injured thousands. Controller power module pm the power module pm is the other routine power source. Heartmate 3 tm configuring the backup system controller. March 5, 2014 thoratec corporation has issued a safety advisory after receiving reports of four deaths and five injuries associated with the heartmate ii lvas pocket system controller. Class 1 device recall heartmate ii implant kit with pocket. The pocket controller is available for new advanced heart failure patients in need who receive heartmate ii as well as for current heartmate ii patients who wish to upgrade their existing system controllers. The following information is provided as a reinforcement of the initial release. This is the most serious formal recall since the issue with the. Over 26,600 heart failure patients have received the heartmate ii lvad. The heartmate ii left ventricular assist system is intended for use both inside and outside of the hospital, or for transportation of left ventricular assist device patients via ground ambulance, airplane, or helicopter. The pocket system controller is a power supply that connects to the implanted lvas pump through a lead driveline under the skin. Its small size and quiet operation make the heartmate ii suitable for a wide range of patients. Heartmate ii pocket controller for thoratec lvad gets u.
Page 1 the heartmate ii lvas pocket system controller has been prescribed for 2,142 patients, either at the time of the implantation of the heartmate ii lvad, or as a replacement for an older controller model epc system controller. Heartmate 3 pocket controller guide michigan medicine. Urgent medical device correction for heartmate ii from. Unplug one system controller power lead from the pm cable. Safety, the worry of cables getting caught on door knobs or tugged on by kids, pets, etc. Battery button 3 button functions push battery button once and you will get the battery fuel gauge push battery button and hold and you will get a selftest when power and driveline is removed, push battery button and hold for 5. Heartmate ii is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. May 24, 2017 the controller helps power the lvas system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Many heartmate ii lvas pocket system controller users face risks. Thoratec urgent medical device correction letter for.
Catalog number 106015 nam 106016 eu all serial numbers. The heartmate ii lvad comes with a lightweight, pocketsized controller that interfaces with the implanted pump. Thor initiated a voluntary worldwide medical device correction in order to update its labeling and training materials for the. Heart failure management products abbott cardiovascular. Fda recalls around 30,000 abbott thoratecs heartmate ii lvas devices. Heartmate ii left ventricular assist system lvas abbott. Deaths prompt abbott recall of thoratec heartmate ii. The controller helps power the lvas system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. Pocket controller the pocket controller is a small computer. Thoratec warns of heart pumps link to 4 patient deaths sfgate. The pocket controller is designed to support the active lifestyles that patients with heartmate ii lvads are leading. Abbottthoratec recalls heartmate ii lvas pocket system. Four deaths linked to heartmate ii lvas pocket controller. Thoratec urgent medical device correction letter for pocket.
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