10 Updates

4 Deaths Linked To Thoratec Heart System

Mar 4 2014, 7:01pm CST | by

Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a...

Filed under: news

 
 
 

19 weeks ago

4 Deaths Linked To Thoratec Heart System

Mar 4 2014, 7:01pm CST | by

Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers “experienced difficulties with the process of changing from a primary system controller to their backup system controller.”

The company said that 8 of the 9 events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller. Two of the deaths occurred in patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first.”

Thoractec said that their investigation did not uncover any device failures. Patients with the Pocket Controller ”should immediately contact their doctor for retraining on use of the device” and receive an updated patient handbook.

The advisory applies to all HeartMate II LVAS Pocket Controllers, which have been available in Europe since August 2012 and the US and Canada since May 2013. The company said that 2,142 Pocket Controllers have been prescribed, either as original equipment with the HeartMate II LVAD or as a replacement for an older controller. Patients who updated from an older controller are at higher risk for complications because they “may not have received adequate training regarding the differences between the two controllers, especially differences related to the connection of the driveline.”

Last November an article in the  New England Journal of Medicine  reported a highly troubling increase in pump thrombosis in patients who received the HeartMate II device.

Source: Forbes Business

 
Update
10

6 weeks ago

RM47mil KWSG contributions still unclaimed

Jun 9 2014 7:54am CDT | Source: Business Times Malaysia

Cambodia's Famous Battambang Circus
KUALA LUMPUR: About RM47 million of contributions in the Teachers Provident Fund (KWSG) still remain unclaimed, the Dewan Rakyat was tol ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
9

6 weeks ago

Gold shop lost almost RM1mil

Jun 9 2014 3:50am CDT | Source: Business Times Malaysia

"GOLDEN ASIA" Tokyo Premiere Press Conference
KANGAR: A gold shop owner lost almost RM1 million after after the safe on in his shop was broken into by r ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
8

6 weeks ago

Motion to debate MAS losses in Dewan Rakyat rejected

Jun 9 2014 3:39am CDT | Source: Business Times Malaysia

The Prince Of Wales Visits The Royal International Air Tattoo
KUALA LUMPUR: AN emergency motion to debate the losses incurred by Malaysia Airlines last year, amounting to RM1.2 billion was reject ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
7

6 weeks ago

MH370 Tragedy: Hisham: RM27.6 mil spent on 1st phase of SAR

Jun 9 2014 2:11am CDT | Source: Business Times Malaysia

KUALA LUMPUR: Malaysia spent some RM27.6 million in its first phase of the search operations for missing Malaysia Airline flight MH370, said Acting Transport Minis ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
6

6 weeks ago

9.1m litres of diesel seized in a month

Jun 8 2014 1:11am CDT | Source: Business Times Malaysia

INDIA-CHINA-DIPLOMACY-TRADE
PUTRAJAYA: The Domestic Trade, Cooperatives, and Consumerism ministry has seized some 9.1 million litres of diesel and property worth RM58 million since mounting ‘Operasi Diesel Sela ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
5

6 weeks ago

Girl, 9, awarded RM2.78m compensation for medical negligence

Jun 6 2014 4:56am CDT | Source: Business Times Malaysia

Government Weekly Cabinet Meeting
KUALA LUMPUR: A nine-year-old girl who suffered brain damage during her birth at a government hospital was awarded over RM2.78 million in co ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
4

6 weeks ago

Malaysia's total trade in April up 12pc

Jun 5 2014 11:52pm CDT | Source: Business Times Malaysia

KUALA LUMPUR: Malaysia's total trade in April 2014 rose by 12 per cent from a year ago to RM123.86 billion due to growing trading activities, International Trade and Industry Minister Datuk Se ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
3

6 weeks ago

Works Ministry to spend RM20m for upgrading works at 50 accident black spots

Jun 4 2014 11:35pm CDT | Source: Business Times Malaysia

Iskandar Johor Open - Previews
JOHOR BARU: The Works Ministry will implement upgrading works at 50 accident prone locations in the country that have been identified this year inv ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
2

6 weeks ago

Najib launches loan scheme for Ramadan traders

Jun 4 2014 10:24pm CDT | Source: Business Times Malaysia

EurAsia Cup presented by DRB-HICOM - Day One
PUTRAJAYA: Prime Minister Datuk Seri Najib Razak today launches RM45 million Ramadan Baz ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 
Update
1

6 weeks ago

Residents bring up objection against Kidex to Suhakam

Jun 4 2014 4:49am CDT | Source: Business Times Malaysia

PETALING JAYA: A group of 20 Petaling Jaya residents held a meeting with the Human Rights Commission of Malaysia (Suhakam) over their objection against the proposed RM2.2 billion Kinrara Damansara Skyway (Kidex) t ...
Source: Business Times Malaysia   Full article at: Business Times Malaysia
 

 

Don't miss ...

 

<a href="/latest_stories/all/all/30" rel="author">Forbes</a>
Forbes is among the most trusted resources for the world's business and investment leaders, providing them the uncompromising commentary, concise analysis, relevant tools and real-time reporting they need to succeed at work, profit from investing and have fun with the rewards of winning.

 

blog comments powered by Disqus

Latest stories

US airlines cancel flights to Israel
Washington, July 23 (IANS) Two major US civil aviation giants, Delta Airlines and US Airways announced Tuesday that they have cancelled flights to Israel due to safety and security concerns.
 
 
China's rotten meat scandal spreads to Japan (Roundup)
Beijing/Tokyo, July 22 (IANS) A rotten meat scandal which led several fast food chains to withdraw some of their most popular dishes in China this week spread to Japan Tuesday, as McDonald's announced it had stopped selling fried chicken.
 
 
Study reports worldwide drop in HIV cases
Sydney, July 22 (IANS/EFE) The number of people with HIV has dropped by 18.7 percent since 2012, according to a report made public at the 20th International AIDS Conference being held in Melbourne.
 
 
China seals McDonald's, KFC supplies after scandal
Beijing, July 22 (IANS) Authorities in China have rushed to seal up suspicious meat products in fast food chains, including McDonald's and KFC, after one of their suppliers was accused of selling stale meat.
 
 
 

Latest from the Network

Russia ready to join probe into airliner crash
Moscow, July 23 (IANS) Russia is ready to join the international investigation led by the International Civil Aviation Organisation (ICAO) into the crash of the Malaysian Airlines MH17, Moscow said Tuesday. "Russia is...
Read more on Politics Balla
 
Kris Jenner to release cookbook
Kris Jenner is releasing her own cookbook. The 58-year-old matriarch has put together some of her best recipes and top tips for entertaining guests in her new book 'In The Kitchen With Kris: A Kollection of Kardashian-...
Read more on Celebrity Balla
 
Zoe Saldana: My husband's tattoo was 'romantic'
Zoe Saldana thought her husband's tattoo of her face was ''the most romantic thing''. The actress' beau Marco Perego - whom she married last year - had her facial features etched onto his arm and, although she tried to...
Read more on Celebrity Balla
 
Jimmy Kimmel cried at daughter's birth
Jimmy Kimmel cried at the birth of his baby daughter. The chat show host, 46, admits he was reduced to tears when he and his wife Molly McNearney welcomed their first child Jane into the world earlier this month....
Read more on Celebrity Balla
 
Lady Gaga is 'curvy and proud'
Lady Gaga is ''curvy and proud''. The 28-year-old singer - who is known for her bizarre outfits - insists she feels comfortable with her own body and gets satisfaction from flaunting it in front of people. The blonde...
Read more on Celebrity Balla
 
US airlines cancel flights to Israel
Washington, July 23 (IANS) Two major US civil aviation giants, Delta Airlines and US Airways announced Tuesday that they have cancelled flights to Israel due to safety and security concerns. According to FlightAware....
Read more on Politics Balla
 
ICAO in Ukraine to analyse MH17 flight recorders
Donetsk/Kiev, July 23 (IANS) A delegation of specialists from the International Civil Aviation Organisation (ICAO) is in Kharkiv, Ukraine's second largest city, for further analysis of the flight recorders from the...
Read more on Politics Balla
 
Why Apple’s iPhone 6 should launch on September 12th
While some reports say the next-gen iPhones will be launched on September 19th – not to mention that some retailers already offer pre-order options of the iPhone 6, despite the fact that it doesn’t yet exist – Business...
Read more on Apple Balla
 
Crazy rumors say thinner iPad mini ‘Air’ is coming soon, 12.9-inch iPad Pro set for 2015
The iPhone 6 may be the hottest device coming from Apple this year, but that doesn’t mean the company has stopped working on some other interesting products. A new report from Taiwan’s Economic Daily News says Apple...
Read more on Apple Balla
 
Dream come true for Buttler, surgery time for Prior
London, July 22 (IANS) New England wicket-keeper Jos Buttler finally gets the Test status after serving as a One-Day cricketer and this, he says, is a "dream come true". Lancastrian Buttler, 23, has played 63 times in...
Read more on Sport Balla