Maquet-Datascope Intra-Aortic Balloon Pump (Mar 2011)

28-March 2011
Datascope states that it has received a small number of reports in which the fan assembly of the above IABPs failed, causing the power supply to detect an overheating event and shut down. This problem may be caused by a misshapen retaining ring becoming disengaged, causing the fan blade assembly to stop rotating. Datascope also states that, because patients receiving IABP therapy are closely monitored in an acute care setting (e.g., cardiac or cardio-thoracic intensive care), this problem presents a low risk to patients. In addition, the "Warnings" section of the operating instructions for the above IABPs instructs users to not leave the patient unattended during IABP therapy.



If this problem were to occur, the clinician should notice a lack of screen activity as well as the absence of an auditory recognition of the balloon inflation/deflation cycle. Under routine circumstances, a patient could be transferred to another IABP in a relatively short amount of time; however, patient risk may increase if a replacement IABP is unavailable (e.g., during patient transport).


Action Needed: Datascope states that, if this problem were to occur, the clinician has the ability to prevent clotting by manually inflating and deflating affected product with air or helium. Refer to the instructions for use of affected product, section D, "Manually Inflating and Deflating a Catheter." This section reiterates that an intra-aortic balloon should not remain inactive for >30 min and provides detailed instruction on how to keep an intra-aortic balloon active during IABP failure. Alternatively, the intra-aortic balloon can be removed. A Datascope service representative will contact your facility to arrange to replace affected power supplies at no cost. Upon replacement of affected product, you will be asked to sign a service repair order.

Source: ECRI Institute

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