A voluntary recall is in effect for certain Intra-Aortic Balloon Pumps (IABPs) sold by Datascope Corporation, for a potential electrical test failure code. This field correction applies as well, to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP, according to the U.S. Food and Drug Administration (FDA). Patients receiving IABP 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, that resulted in a patient’s death. The complaint concerned 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.
Device Failure Cause
The company said the electrical test failure code was caused by a solenoid (cylindrical coil of wire acting as a magnet when carrying electric current) valve that required more power than the solenoid driver board could deliver to open the valve. Datascope warned of additional dangers related to static conditions in which the balloon will not inflate or deflate and could interrupt therapy, MassDevice.com reports.
To avoid the complication, the company recommended powering on the IABP prior to insertion to allow for the successful completion of a self-test, which it says would take less than 60 seconds to perform, according to the FDA notice. Datascope advised not leaving users unattended during IABP therapy due to the potential problem, and said that if electrical test failure code #58 is observed, the operating physician should remove the IABP.
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.
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Function of an Intra-Aortic Balloon Pump
An intra-aortic balloon pump (IABP) is a mechanical device that helps the heart pump blood. The balloon pump is inserted into the aorta, the body’s biggest artery. It is a thin, long tube called a catheter with a balloon on the end of it. Done normally in a hospital setting, the doctor will insert an IABP. The area of the leg will be numbed by the physician who will then 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 used during this procedure will help to accurately position the IABP, according to WebMD.
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 Intra-Aortic Balloon Pump Works
The IABP reduces the workload on the heart, allowing the heart to pump more blood. The IABP is inserted into 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.
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 contracted, the balloon inflates. This inflation helps increase blood flow to the heart and the entire body. As the left ventricle is about to pump out blood, the balloon deflates. This deflation creates extra space in the aorta, allowing the heart to pump out more blood.
IABPs may have some adverse side effects. An IABP may 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 uncomfortable. When this device is in place, the patient must lie extremely still, reports WebMD.
Scope of Affected Units
Datascope 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.
Devices distributed after December 11, 2013 are not affected by the field correction notice, according to MassDevice.com.
Legal Help Regarding IABPs
If you or someone you know has been involved in an incident involving medical negligence or complications with a medical device, you may have valuable legal rights. Parker Waichman law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).