jueves, 24 de diciembre de 2015

Medical Device Safety and Recalls: Notification of Three Recalls

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Recalls have been issued for the following three medical devices.  Please click the links for additional information

Draeger Perseus A500 Anesthesia Workstation - Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly.  If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen.  This could cause patients to suffer serious adverse health consequences, including injury or death. The company has received one report of this issue occurring, with no injuries and no deaths.
Insulet Corporation OmniPod Insulin Management System - The Pod's needle mechanism may fail or delay in inserting the needle. If the needle mechanism fails or there is a delay, the needle will not be inserted in the patient's skin and insulin delivery will not begin. The interruption of insulin delivery may lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or even death. The firm has received 10 cases where the malfunction occurred.  No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots. 
Boston Scientific Corporation, Chariot Guiding Sheath - Boston Scientific has received fourteen complaints of the shaft of the device separating. This can cause small pieces to break off the device and enter the patient’s bloodstream. This could obstruct blood flow and require additional interventions to remove device fragments. Obstructed blood flow can result in serious patient injuries such as stroke, kidney damage, damage to the intestines or limbs, or can cause patient death.

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