{"id":591,"date":"2017-04-04T13:18:29","date_gmt":"2017-04-04T12:18:29","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=591"},"modified":"2017-04-04T13:19:22","modified_gmt":"2017-04-04T12:19:22","slug":"heart-pump-device-production-halted-due-patient-death","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/heart-pump-device-production-halted-due-patient-death","title":{"rendered":"Heart pump device production has been halted due to patient death"},"content":{"rendered":"<p>A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient.<\/p>\n<p>Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe.<\/p>\n<p>The device was initially thought to be commercially promising, but the problems identified are serious.<br \/>\n<!--more--><\/p>\n<h2>About the heart pump<\/h2>\n<p>The medical device was praised by both medical manufacturers, St. Jude and Abbott Laboratories, as a device that was in advanced clinical testing.<\/p>\n<p>The blood pump consists of a propeller inside a thin wire cage that is inserted in the heart to keep blood flowing at a predictable rate for up to 6 hours when patients are undergoing high-risk surgery to unblock clogged blood vessels. The advantage of such a device is to allow doctors\/surgeons to place the device in the heart without needing to perform open-heart surgery.<\/p>\n<h3>Recall<\/h3>\n<p>Issue were first addressed by regulators in Germany. On 6<sup>th<\/sup> February 2017, a recall note was issued asking for use of all devices to be halted, and for devices to be returned.<\/p>\n<p>Abbott Laboratories said it received 8 reports of the medical pumps stopping during high-risk surgical procedures, and notes that in one case, the problem caused an irregular blood flow which necessitated emergency intervention to save a patient&#8217;s life.<\/p>\n<p>Another case reported that a patient died as a result of &#8220;sepsis several days after the intervention&#8221;.<\/p>\n<h3>Numbers affected<\/h3>\n<p>Abbott Laboratories noted that 8 problems affected some 1.9% of the devices shipped from the factory. This implies that approximately 420 devices are potentially affected by the recall notice.<\/p>\n<p>The recall noted: <\/p>\n<blockquote><p>&#8220;Abbott is temporarily pausing the use of HeartMate PHP devices to allow the company time to evaluate and implement corrective actions&#8230; In the interim, do not use units within your possession\u2026 Hospitals will be required to return all HeartMate PHP catheter inventory to Abbott.&#8221;<\/p><\/blockquote>\n<h3>A commercially viable device?<\/h3>\n<p>The medical manufacturer has also suspended a patient study (Shield II) which involved 425 individuals testing the HeartMate PHP and a similar heart pump device manufactured by Abiomed. Abbott Laboratories confirmed that the suspension of the trial was due to uncertainty of the safety of such devices. Abbott Laboratories&#8217; spokesperson, Justin Paquette, said: &#8220;&#8230;the pause in our U.S. study and commercial implants [in Europe]&#8230; are being taken as a precaution due to reports of a low number of clinical events associated with pump stoppage&#8221;.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient. Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe. The device was initially thought &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/heart-pump-device-production-halted-due-patient-death\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Heart pump device production has been halted due to patient death<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":389,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[8],"class_list":["post-591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-recalls"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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Models CS100, CS100i and CS300 are reportedly at risk of \"haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.\"\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1075,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/another-medical-device-alert-intra-aortic-balloon-pump-fault","url_meta":{"origin":591,"position":1},"title":"Another Medical Device Alert for Intra-Aortic Balloon Pump for a different fault!","author":"Admin","date":"10th November 2017","format":false,"excerpt":"The Medicines and Healthcare products Regulatory Agency (MHRA) has issued another medical device alert for intra-aortic balloon pumps, made by Maquet\/Getinge. 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This new alert identifies a \"false blood detection\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical device alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1081,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/mechanical-heart-valves-alert-over-risk-inverted-implantation","url_meta":{"origin":591,"position":2},"title":"Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation","author":"Admin","date":"13th November 2017","format":false,"excerpt":"Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting,\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical device alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":107,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/accu-chek-insight-insulin-pump-system-prone-to-insulin-leaks-risk-of-hyperglycaemia","url_meta":{"origin":591,"position":3},"title":"Accu-Chek Insight insulin pump system prone to insulin leaks &#8211; risk of hyperglycaemia","author":"Author","date":"30th August 2016","format":false,"excerpt":"A Medical Device Alert has been issued with the Medicines and Healthcare products Regulatory Agency (MHRA) for the Accu-Chek Insight insulin pump system using NovoRapid PumpCart cartridges which is reportedly prone to leakage. Leakage of the devices, manufactured by Roche Diabetes Care, could lead to serious consequences for users, which\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1095,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/accu-chek-insight-insulin-pump-alarm-failure-risk","url_meta":{"origin":591,"position":4},"title":"Risk of alarm failure in Accu-Chek Insight insulin pumps could lead to hyperglycaemia","author":"Admin","date":"17th November 2017","format":false,"excerpt":"Another issue with insulin devices. These life-saving devices are so important in modern society, so any issue with them is huge. Diabetics and healthcare providers are urged to check Accu-Chek Insight insulin pump display screens regularly as the alarms on the devices may reportedly fail due to an electrical error.\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":767,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/accu-chek-insight-insulin-pumps-battery-life-issues","url_meta":{"origin":591,"position":5},"title":"Issues with battery life of the Accu-Chek Insight insulin pumps","author":"Admin","date":"26th June 2017","format":false,"excerpt":"All Accu-Chek Insight insulin pumps have received new instructions for better device management due to previous complaints about the battery lifetime and the device having unexpected shutdowns. The first warning for the medical device was issued on the 4th August 2015 where Roche Diabetes Care, the medical manufacturers of the\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/591","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=591"}],"version-history":[{"count":3,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/591\/revisions"}],"predecessor-version":[{"id":595,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/591\/revisions\/595"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/389"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}