On September 6, 2017, Datascope Corp./MAQUET recalled its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps (IABPs) due to false blood detection alarms and ingress of fluid into the device. If a patient requires circulatory support with an IABP and the device does not work, or if therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including 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.
To clear a false blood detection alarm, clinicians must follow the instructions on the Blood Detection Alarm Help Screen to validate or clear the alarm. The issues surrounding ingress of fluid into the device appear to be the result of the accumulation of water condensation.
Datascope Corp./MAQUET recommended that the risks and benefits of using an affected CS100i, CS100, or CS300 IABP be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available.
The recall affected all lots manufactured between July 1, 2003, and June 16, 2017. The recalled products were distributed between March 24, 2003, and June 16, 2017. In the U.S., the recall affected 5,049 devices.
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 FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives Report: Diagnosis and Treatment of Heart Attacks: Liability Issues