Surgery can be a terrifying experience. Whenever a patient goes to a hospital he or she has to rely on medical professionals to do what is best for him or her. But in the case of surgery, the patient is usually not even away or aware during the procedure. So there is no way of knowing what is going on. The patient has to trust completely in the doctors, nurses, and other medical support staff. But the patient also has to trust completely in the people who design and manufacture the tools the medical professionals use. Unfortunately, sometimes the tools fail, leaving the patient suffering from personal injury.
The Food and Drug Administration (FDA) announced that Datascope Corp/MAQUET issued a worldwide recall of intra-aortic balloon pumps. Specifically, the pumps being recalled are the 98/98 XT, the CS100, the CS100i, and the CS300. They are being recalled due to potential mechanical failure of the power supply fan assembly. Approximately 12,360 affected units have been sold globally. This is another case of what is called “medical device error.”
According to the FDA, intra-aortic balloon pumps are electromechanical systems used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart. The devices rely on the principle of “counterpulsation.” Counterpulsation is defined by MedicineNet as:
A technique that synchronizes the external pumping of blood with the heart’s cycle to assist the circulation and decreasing the work of the heart. Counterpulsation pumps when the heart is resting to increase blood flow and oxygen to the heart. Counterpulsation stops pumping when the heart is working to decrease the heart’s workload and lessen oxygen demand.
The FDA has classified the recall as a “Class 1” recall. It defines this type of recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” This is the most serious type of recall there is.
In its announcement the FDA announced that there have been no reported patient injuries or deaths related to the power supply malfunction. However, just because none have been reported, that does not mean none have happened. It is entirely possible that, due to lack of knowledge about the malfunction up until now, the malfunction could have caused deaths or injuries without patients or medical professionals realizing what the cause was.
The FDA says that all of the medical agencies that purchased these defective products have been informed of the recall. But that does not mean that the patients who the defective equipment was used on have been notified. Nor does it mean that the families of those the devices were used on who did not survive have been notified. If you believe that you or your loved one had such a device used, and something went wrong during the surgery that could be attributed to the malfunction, you should contact a medical malpractice attorney to examine your options.