CareFusion has updated its AVEA® ventilator recall, according to the U.S. Food & Drug Administration (FDA), which has designated this action as a Class I recall, its most serious designation. A Class I recall is defined a situation in which a reasonable probability of serious adverse health consequences or death is associated with use of the defective units.
There is no change to CareFusion’s previously announced remediation plans and CareFusion is actively remediating hardware on affected units. This recall affects AVEA ventilators and spare parts made between March 1, 2009 and June 30, 2011 and does not affect CareFusion’s current production or shipping processes.
In September 2011, CareFusion sent an urgent Medical Device Recall Notification to customers outlining the identified potential risks linked to AVEA ventilators and that affected units may produce an extended high Ppeak alarm. This alarm initiates audio and visual alarms, which are followed by the opening of the safety valve. When this alarm condition occurs, no breaths are delivered; instead, the safety and exhalation valves open, allowing the patient to breathe from room air and activating the safety valve alarm.
CareFusion determined the root cause for this issue and said it is updating each device so that customers only experience minimal disruption. Detailed information can be accessed on its website at: http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-avea-ventilator.aspx. CareFusion Technical Support can be reached, toll-free at 1.800.554.8933.
This is not the first time CareFusion has had to recall a medical device. We recently wrote that CareFusion EnVe Ventilators, model 19250-001, manufactured between December 2010 and May 2011, were recalled in what the FDA deemed a Class I recall.
The CareFusion EnVe Ventilator is a portable ventilator used to provide breathing assistance to pediatric and adult patients in hospital and medical transport settings. The recall was issued after CareFusion identified potential defects that can interrupt ventilation to the patient, including a potential delay in resuming ventilation after reconnection, a potential automatic reset, and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.
Before that, CareFusion issued a recall for its Alaris PC Units (Model 8015) electronic infusion pumps in what was deemed a Class I recall by the FDA. The recall was initiated on July 13, 2010 because, under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down, resulting in a delay or interruption in therapy, which could lead to serious injury and/or death.