This pocket controller can help new patients and the more than 6,000 patients currently on heartmate ii support. The controllers monitor the heartmate ii and warn patients if the battery charge is running low. Mar 05, 2014 thoratec heartmate ii pocket controllers linked to four deaths march 5, 2014 written by. 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 3 pocket controller flashing yellow diamond alarm what is a flashing yellow diamond alarm. Apr 02, 2014 thoratec heartmate ii pocket controller recall issued after deaths april 2, 2014 written by. Safety, the worry of cables getting caught on door knobs or tugged on by kids, pets, etc. Class 1 device recall heartmate ii left ventricular assist.
Thor initiated a voluntary worldwide medical device correction in order to update its labeling and training materials for the. Prioritized visual alarms with clear, actionable instructions. Patients should contact their centers to learn more about the heartmate ii system and the new pocket controller. The heartmate ii lvadheartware hvad function is sensitive to changes in blood. Deaths prompt abbott recall of thoratec heartmate ii controllers. Keeping it inside your clothes is a great way to hide and protect it. Thoratec warns of heart pumps link to 4 patient deaths sfgate. Heartmate ii lvas instructions for use featuring the mobile. Heartmate ii left ventricular assist system instructions for use iii. Abbottthoratec recalls heartmate ii lvas pocket system. Fda recalls around 30,000 abbott thoratecs heartmate ii lvas devices. 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. Heartmate ineedhelp patient referral triggers pocket card. The heartmate ii lvas pocket system controller is intended for use inside or outside of the hospital. Look at the lights next to the charging pocket for the battery. Of the reported cases, 26 resulted in patient death and 19 involved serious.
The mount sinai medical center first in new york city to. Having that controller secure so it never gets bumped hard or falls, is something we constantly worry about. Fda recalls around 30,000 abbottthoratecs heartmate ii. Heartmate ii lvas pocket system controller recall following.
Abbottthoratecs heartmate ii left ventricle assist lvas pocket system controller has been the center of multiple recalls since the device injured thousands of people. Abbottthoratecs heartmate ii left ventricle assist lvas pocket system controller has been the center of multiple recalls since the device injured thousands. This latest generation controller for the heartmate ii left ventricular assist device lvad is a new small, lightweight, patientfriendly external controller about the size. It is either in the seam or the little pocket next to the battery depending on your size. 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. The controller is powered by batteries or connected to a main power supply.
For outside battery pockets, find the hole for the cord to exit the vest. 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. Thoratec corporation issues worldwide urgent medical. Thoratec urgent medical device correction letter for. Heartmate ii the heartmate ii is surgically implanted just below the diaphragm in the abdomen. 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. 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. This is the most serious formal recall since the issue with the. The fda issued a class i recall against heartmate ii left ventricle assist lvas pocket system controller manufacturer, abbottthoratec. 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. The michael brady lynch firm offers case evaluations at no cost or obligation to you. Fda approval of heartmate ii pocket controller todays.
Urgent medical device correction for heartmate ii from. Class 1 device recall heartmate ii implant kit with pocket. Patientfamily education teaching protocol heartmate ii. Clearance may 17th, 20 medgadget editors cardiac surgery, cardiology thoratec received fda clearance to offer its pocket controller for.
If you are a heartmate ii lvas patient and the serial number on your system controller starts with the letters pc i. Thoratec warns of heart pumps link to 4 patient deaths. The heartmate ii is a left ventricular assist device lvad. Injuries and deaths linked to heartmate ii lvas pocket system controller. Thoratec heartmate ii pocket controllers linked to four. Abt recalled its heartmate ii lvas pocket system controller due to risk of patient injury andor death during backup controller exchange. Heartmate ii pocket controller for thoratec lvad gets u. The heartmate ii lvad comes with a lightweight, pocketsized controller that interfaces with the implanted pump.
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. Catalog number 106015 nam 106016 eu all serial numbers. The pocket controller is lighter and more compact than previous lvad system. Prioritized visual alarms provide clear, actionable instructions. Patientfamily education teaching protocol heartmate ii left. Aug 10, 2016 a brief introduction to the most common audio alarms ems may encounter with the heartmate ii lvad controller. Backup battery provides at least 15 minutes of full power in an emergency situation. The bosco lvad vest was designed to help my husband manage the external equipment that came with his left ventricular assist device lvad, the heartmate ii by thoratec corporation. Heartmate ii lvad is indicated for patients in nyha class iiib and iv, and is clinically proven for both short and longterm support. Food and drug administration fda to market the heartmate ii pocket controller, the small, smart, safe face of the heartmate ii lvad system.
These products are intended for use by or under the direction of a physician. 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. Heartmate 3 pocket controller guide controller key functions and alarms. Heartmate 3 tm mobile power unit alarms for clinicians. Thoratec offers added info regarding heartmate ii lvas. 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. 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. Pocket controller the pocket controller is a small computer. 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. Thoratec issues urgent labeling correction for heartmate. Its small size and quiet operation make the heartmate ii suitable for a wide range of patients. Thoratec received fda clearance to offer its pocket controller for patients using the companys heartmate ii lvad left ventricular assist device. Thoratec issues urgent labeling correction for heartmate ii.
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. Patients are at risk of problems when exchanging an older controller for the pocket controller. 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. Thoratec heartmate ii pocket controller recall issued. Thoratec has announced that four patients have died and at least five. Abbott abt recalls heartmate ii lvas pocket system. Thoratec announces fda approval of heartmate ii pocket.
Unplug one system controller power lead from the pm cable. Heartmate 3 tm lvas surgical hand tools instructions for use. Patients with the heartmate ii have a 2 year survival rate 7xs greater than medical therapy alone 58% slide 12 bridge to transplant. Heartmate ii 3 system components hmii pocket controller power module mpu mobile power unit battery charger and batteries hm3 pocket controller. Thoratec heartmate ii lawsuit lvad device failure death.
Heart failure management products abbott cardiovascular. 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. Thoratec heartmate ii instructions for use manual pdf download. Thoratec heartmate ii pocket controllers linked to four deaths march 5, 2014 written by. Mount sinai medical center first in new york to offer. Thoratec corporation lvad recall gets class i status.
It acts as a conduit by attaching to the left ventricle and then to the aorta, leaving natural circulation in place. Heartmate 3 pocket controller flashing yellow diamond alarm. The company released a new version of the pocket controller in august 2012 in europe, and then in. The pocket system controller is a power supply that connects to the implanted heartmate ii lvas pump through a lead driveline under the skin. Controller power module pm the power module pm is the other routine power source. Apr 12, 2017 heartmate 2 3 pocket controller change. 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 left ventricular assist system lvas by. 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.
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. 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. 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. A backup system controller is provided to each patient in the event of a device alarm or malfunction. Heartmate 3 pocket controller guide michigan medicine. The heartmate ii is abbotts firstline intermediatetochronic left ventricular assist device. Four deaths linked to heartmate ii lvas pocket controller.
May 24, 2017 home deaths prompt abbott recall of thoratec heartmate ii controllers. 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. Illustrations are artists representations only and should not be considered as engineering. When the pm is plugged into an electrical outlet, it provides ac electrical power to the system. 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 fda has determined that a warning issued by last month by thoratec.
The pocket system controller is a power supply that connects to the implanted heartmate ii lvas pump through a. Heartmate 3 tm guide to replacing the running system controller with the backup controller for clinicians. Heartmate ii left ventricular assist system lvas abbott. As of february 4, 2014, thoratec has received four 4 reports 0. 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. Our life depends on a machine, protecting this machine is a primary concern and stress. Over 26,600 heart failure patients have received the heartmate ii lvad. The heartmate ii left ventricular assist system duration. Thoratec offers added info regarding heartmate ii lvas pocket. Heartmate 3 tm configuring the backup system controller. 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. Thoratec corporation announces fda approval of heartmate.
Food and drug administration fda, to help its advanced heart failure patients maintain more active lifestyles. The yellow diamond alarm indicates low external battery power. 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 lvas is designed to provide years of. Thoratec heartmate ii pocket controller recall issued after. The following information is provided as a reinforcement of the initial release. Many heartmate ii lvas pocket system controller users face risks. Heartmate ii left ventricular assist device lvad abbott. Mar 06, 2014 thoratec warns of heart pumps link to 4 patient deaths thoratecs stock drops after warning about heartmate ii. Thoratec updates heartmate ii controller warning massdevice.
Pocket system controller will not communicate with system monitor. Thoratec urgent medical device correction letter for pocket. 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. 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. Bosco lvad vest mobility restored for lvad patients.
Deaths prompt abbott recall of thoratec heartmate ii. Thoratec corporation lvad recall gets class i status biospace. 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. 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. 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. The pocket controller is designed to support the active lifestyles that patients with heartmate ii lvads are leading. The pocket system controller is a power supply that connects to the implanted lvas pump through a lead driveline under the skin.
1110 565 809 279 761 631 293 1402 1493 1553 393 1196 640 612 981 818 378 1226 1595 812 200 226 307 1223 1223 1392 275 1114 952 1110 279 1247 1278 205 1204