The U.S. Food and Drug Administration (FDA) released information on a select voluntary recall from Getinge’s Datascope and Maquet of its System CS100, CS 100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures. Patients receiving IABP (intra-aortic balloon pump) therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic (mechanics of blood circulation) instability.
Datascope announced they received a complaint in which the device failed to initiate therapy, resulting in a patient’s death. The complaint involved a CS300 IABP device which failed to pump due to electrical test failure code #58, a maintenance code #3, and an autofill failure, according to the FDA notice.
Cause of the Device Failure
The company said the electrical test failure code was triggered by a solenoid (cylindrical coil of wire acting as a magnet when carrying electric current) valve requiring more power than the solenoid driver board could deliver to open the valve. Datascope warned of additional associated dangers related to static conditions in which the balloon will not inflate or deflate and could interrupt therapy, reports MassDevice.com.
To avoid the complication, the company suggested powering on the IABP prior to insertion to allow for the successful completion of a self-test, which it says will take less than 60 seconds to perform, according to the FDA statement. Datascope advised not leaving users unattended during IABP therapy due to the error, and said that if electrical test failure code #58 is observed, the operating physician should remove the IABP.
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A warning from the FDA says the patient balloon should not remain inactive in the patient (not inflating or deflating), for more than 30 minutes due to the potential for thrombus (blood clot) formation.
What is an Intra-Aortic Balloon Pump?
An intra-aortic balloon pump (IABP) is a mechanical device that helps the heart pump blood. The device is inserted into the aorta, the body’s largest artery. It is a long, thin tube called a catheter with a balloon on the end of it. Done typically in a hospital setting, the doctor will insert an IABP. The area of the leg will be numbed and the physician will thread the IABP through the femoral artery in the leg into the aorta. The IABP will then be positioned at the center of the aorta, below the heart. An X-ray machine will be used during this procedure to help accurately position the IABP, according to WebMD.
An IABP may be used to stabilize a person who is in the hospital for acute mitral valve regurgitation or severe heart failure. An IABP is normally used for a short period of time, such as hours or days. A long-term treatment will likely be needed, such as valve surgery or the insertion of a left ventricular assist device (LVAD).
How an IABP Works
The IABP reduces the workload on the heart, allowing the heart to pump more blood. The IABP is placed inside the aorta, the artery that takes blood from the heart to the rest of the body. The balloon on the end of the catheter inflates and deflates with the rhythm of the heart. This helps the heart pump blood to the body.
The IABP improves the function of only the left ventricle, since this is the chamber that pumps blood into the aorta. After the left ventricle has finished contracting, the balloon inflates. This inflation helps increase blood flow to the heart and the rest of the body. As the left ventricle is about to pump out blood, the balloon deflates. This deflation creates extra space in the aorta, permitting the heart to pump out more blood.
IABPs may have some side effects. An IABP can cause an infection in the bloodstream if it is used for too long. The balloon may overinflate and tear the aorta. The IABP is also somewhat inconvenient. If one of these devices is in place, the patient must lie extremely still in the hospital bed, reports WebMD.
Scope of Affected Units
The company estimated that there are about 12,000 affected units sold globally (in over 100 countries), distributed between Mach 23, 2003 and December 11, 2013. The recall affects CS100i devices with part numbers 0998-UC-0446HXX and 0998-UC-0479HXX, CS100 devices with part numbers 0998-00-3013-XX and 0998-UC-3013-XX, according to the FDA release.
Units distributed after December 11, 2013 are not affected by the field correction notice, according to MassDevice.com.
Legal Help and Information Concerning Medical Issues
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