Maquet’s Intra-Aortic Balloon Pumps (IABPs) have been the subject of a Class I recall. The firm received 106 reports of device malfunctions including one death. The firm determined that the fan assembly for the affected IABPs could contain a misshapen retaining ring. This retaining ring could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning.
This device failure would cause the balloon to stop inflating and deflating. It may result in decreased blood flow to the heart and the rest of the body, difficulty in weaning the patient from cardiopulmonary bypass, and clotting or blockage of blood vessels to the intestines, kidneys, or legs. The possible long range consequences of this include organ injury or tissue damage, possibly leading to patient death.
An intra-aortic balloon pump is a mechanical device that inflates a balloon placed in the patient’s thoracic aorta. The balloon inflates and deflates in order to help the heart pump blood, increase blood flow to the heart itself, and increase blood flow to the rest of the body. The device is used temporarily for emergency cardiac support conditions, such as after a heart attack, for severe heart failure, or while the patient is waiting for heart surgery.
IABP System 98/98XT, CS100/CS100i, and CS300 were recalled. The IABPs were manufactured by Maquet Datascope Corporation, Wayne, NJ, from January 1, 2003, through June 30, 2011, and distributed from January 17, 2003, through June 30, 2011.
A recalled pump may continue to be used until a repair or replacement is performed. However, there should be heightened awareness that a sudden pump failure may occur without warning, and a backup pump should be available for immediate substitution in the case of a failure. If an alternative pump is unavailable and a failure occurs, the balloon should be removed from the patient as soon as possible according to standard procedures. This could result in added risk to the patient.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues