Datascope Intra-Aortic Balloon Problems Resulted In Patient Death, FDA Warns

Approximately 12,000 aortic balloon pumps are subject to a field correction notice, which warns that one of the devices experienced an electrical error code, causing a patient death after it stopped working unexpectedly.

The FDA announced a Datascope Corporation Intra-Aortic Balloon Pump field correction notice on June 19, after receiving a report of a patient death due to the failure of the device to initiate blood flow therapy due to an electrical test failure. To date, the FDA is aware of the one fatality report and no other adverse health events.

The devices requiring corrective action are Intra-Aortic Balloon Pumps (IABPs) that are designed to help the heart pump blood by inserting a catheter with a balloon into the femoral artery in your leg which is threaded to the aorta, the artery that takes blood from the heart to the rest of the body.

The IABPs are designed to reduce the workload of the heart, in return allowing the heart to pump more blood. The balloon on the end of the catheter inflates and deflates with the rhythm of the heart to assist blood flow to the rest of the body.

Patients who are hospitalized and receiving IABP therapy are generally in critical condition and any sudden interruption of therapy could result in serious adverse health consequences, including death.

According to the FDA, manufacturing company Datascope has received a complaint regarding a CS300 IABP device that did not pump due to an electrical test failure code displaying code #568, which is a power up vent test failure. The device was also recorded to have displayed maintenance code #3 which is an autofill failure.

An investigation discovered the solenoid valve may require more power than the solenoid driver board may be able to deliver to allow the valve to open. In this event, the device will fail to initiate power and cause either delays or complete failure of the device to turn on to delivery emergency treatment.

Included in the field corrective notice are System CS100, CS100i and CS300 IABPs, and also any System 98 or System 98XT IABP that was converted to a CS100i or CS300.

Approximately 12,000 of the devices were manufactured by Datascope Corporation of Mahwah, New Jersey where they were distributed for sale throughout the United States, and over 100 other countries to healthcare facilities and medical providers from March 23, 2003 to December 11, 2013.

The FDA has not yet decided the correction constitutes a recall, and urges healthcare professionals to weigh the risk-benefit of using the affected IABP devices when no other alternative option is available.

To ensure working status until the service is performed, healthcare professionals should power on the IABP prior to inserting the IAB catheter to allow the device to successfully complete its one-minute self-test. In the event the device exhibits the electrical test failure code 58, medical personnel should remove the IABP from service immediately and contact the Maquet/Getinge Service Team for immediate service.

Datascope announced it will be scheduling on-site repair services for those with affected devices, in which a technician will replace the defective solenoid driver boards. Customers with additional questions or concerns regarding the recall may contact the Customer Service Department at 1-888-627-8383 and select option 2. All healthcare professionals are being encouraged to report any adverse health events or device failures to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.