The worldwide field correction, issued February 2012, is for the C20, C30, and C40 FLOW-i Anesthesia Systems and the recall were related to a software problem with the MAN/AUTO switch used for changing between manual and automatic ventilation modes. The corrective action associated with this field correction included upgrading the affected systems’ software and providing new corresponding user’s manuals.
The FDA designated the recall as a Class I, which means that this recall involves a situation in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. This action only affects FLOW-i Anesthesia Systems distributed between May 2010 and December 2011.
In specific C20, C30, and C40 FLOW-i Anesthesia Systems, if the MAN/AUTO switch was not fully engaged in either an “ON” or “OFF position, but rather was placed in an “in-between position” for more than five seconds, Technical Alarm TE 613 may have been generated. Activation of this alarm causes the system to remain in the original mode selected and does not switch the ventilation mode. To deactivate the Technical Alarm TE 613, the system must be restarted.
Maquet advises that the local Maquet Technical Support department should be contacted for additional information regarding this closed field correction. U.S. Technical Support can be reached, Monday through Friday, from 8:00 a.m. to 7:00 p.m., Eastern Standard Time (EST), toll-free, at 1.888.627.8383; press option 2, followed by option 1.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program, toll-free at 1.800.FDA.1088; by fax at 1.800.FDA.0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or on the MedWatch web site at www.fda.gov/medwatch.
Last year, we wrote that a defective fan in its power supply might cause overheating and shut down of specific Maquet Datascope’s Intra-Aortic Balloon Catheter Pumps without visible or audible alarms. That recall was also designated a Class I and was initiated on March 16, 2011 by Maquet Datascope Corporation’s Cardiac Assist Division. The recall was implemented over unanticipated interruption of therapy, which might include the inability to decrease already-present ischemia, thrombus formation, organ injury, or other serious events. The intra-aortic balloon pump (IABP) is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart during cardiac surgery.
Datascope Corp/Maquet initiated a voluntary worldwide field correction of certain IABPs prior to the recall when, in specific units, the fan assembly of the power supply could potentially contain a misshapen retaining ring, which could disengage within the fan, causing the fan blade assembly to stop rotating. Consequently, the power supply would detect an overheating event, and shut down without visual or audible alarms.