360° Coverage : 4 Deaths Linked To Thoratec Heart System

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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...

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25 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

 
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2

1 day ago

Khazanah throws MAS RM6b lifeline

Aug 29 2014 5:01pm CDT | Source: Business Times Singapore

August 30, 2014 1:15 AMKHAZANAH Nasional will inject RM6 billion (SS$2.4 billion) over three years to resuscitate loss-making Malaysia Airlines (MAS) under a recovery plan that includes even an Act of Parliament. Other key moves are migrating its operations, assets and liabilities to a new company ( ...
Source: Business Times Singapore   Full article at: Business Times Singapore
 

 
Update
1

2 days ago

MAS posts loss of RM307m for Q2

Aug 28 2014 5:00pm CDT | Source: Business Times Singapore

August 29, 2014 1:13 AMMALAYSIA Airlines (MAS) registered a loss of RM307 million (S$122 million) for the second quarter to end-June, but warned of worse to come in the second half when the "full financial impact of the double tragedies of MH370 ...
Source: Business Times Singapore   Full article at: Business Times Singapore
 

 

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