Friday, May 29, 2015

CareFusion Issues Update to a Recall of Ventilators

CareFusion has updated a global voluntary recall of the firm’s AVEA®® ventilators, which was initiated on April 21, 2015.

The recall, designated a Class I recall by the U.S. Food and Drug Administration (FDA), was issued due to a potential malfunction of an AVEA® ventilator specific 5 psi pressure transducer. The affected devices may develop a failure mode over a period of time, which can cause the ventilator to activate false Extended High Peak or Circuit Occlusion audio and visual alarms, which opens the safety valve and stops ventilating, exactly as the device is designed to do. Should this occur, alternate ventilation support is necessary to reduce the potential of hypoxemia (low blood oxygen) or hypercapnia (abnormally high carbon dioxide levels in the blood), according a press release. A Class I recall indicates a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

The affected AVEA® ventilators were manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. CareFusion learned of the problem via customer reports identifying Extended High Peak or Circuit Occlusion alarms. The device is used only in hospitals and other health care facilities and is intended for continuous breathing support for neonatal through adult patients, the press release explains.

CareFusion instructs in the news release that if an AVEA® ventilator exhibits a sustained Extended High Ppeak or Circuit Occlusion alarm followed by the opening of the safety valve that cannot be cleared by powering the ventilator off and back on again, a healthcare worker should immediately take the device out of service and ventilate the patient in an alternative fashion.

The full list of affected models can be viewed here. Users should refer to Figure 1 for the location of model and serial numbers.

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from Parker Waichman http://www.yourlawyer.com/blog/carefusion-issues-update-to-a-recall-of-ventilators/

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