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Misuse of medical device leads to 4 deaths, 5 injuries

Many Nashville residents have come to depend on their medical devices and take extra care to monitor whether any recalls have been issued on the products they use. Recalls, however, are not the only issues with which consumers should be concerned. Sometimes devices can injure people without being considered a malfunctioning medical product because they are causing injuries not due to a design or manufacturing defect, but because they are being used improperly.

Four deaths and five injuries have resulted from the misuse of the HeartMate II Pocket System Controller, manufactured by Thoratec Corporation. Improper training is cited as the primary reason for these incidents, as changes have been made in the way newer models should be used. Reports do not indicate whether the company made any attempts to retrain physicians or consumers when these changes were introduced. There are currently over 2,000 Pocket Controllers in worldwide distribution.

The Pocket Controllers are not being recalled, as they are accurately labeled and meet their specifications and quality control standards. Instead, physicians are being advised to review the product’s label and retrain any relevant personnel, caregivers and affected patients.

Dangers from medical products do not always stem from defects or result in a medical device recall. Sometimes labeling issues or improper instructions on how to use these products can lead an individual to suffer an injury or a worsened medical condition. Those who experience any type of injury as a result of a medical device may be entitled to compensation to help cover medical expenses and other losses. If you want to pursue legal action against a medical device manufacturer, you may wish to consult with an attorney.

Source: FDA.gov, “Thoratec Corporation Issues Worldwide Urgent Medical Device Correction Letter to Update its Labeling Regarding the Use of the HeartMate II LVAS Pocket System Controller,” Mar. 4, 2014

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