Quick action on a smoking pump leads to worldwide recall, FDA appreciation

On June 2, the screen went blank and smoke billowed out of the back of an intra-aortic balloon pump that was helping a patient’s heart beat after a procedure in TMC’s Cardiac Cath Lab. By June 6, Marquet Datascope Corp. issued a worldwide recall of its device.

As a result of its proactive response, TMC received a certificate for “Outstanding Contribution in Promoting Patient Safety With Medical Devices” from the U.S. Food & Drug Administration.

A few months earlier, the manufacturer had issued a voluntary field correction, but with the smoldering device reported from TMC, the FDA determined that the action needed was a Class I recall, the most serious, used for “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.”

And while our patient experienced no harm as a result, the manufacturer said in its recall that “This device failure may result in unanticipated interruption of counterpulsation therapy.”

Gerri O’Neill, RN, patient safety nurse in the Quality department, reported the event to the FDA. She explained that she investigates every event involving supplies or equipment that could have caused harm and reports them to the FDA.

“I investigate the incident, sequester the equipment and then, if warranted, report it to the FDA,” O’Neill said. She estimates that, on average, she receives a report a day. Examples include guide wires breaking off, warming blankets not warming or a stent that turns out to be defective.

This was the first report in recent memory that resulted in such high-level and immediate action by the FDA, which has the online reporting tool, MedWatch, to allow for timely reporting on safety issues and serious adverse events.

“This past year, we’ve really stepped up our efforts to educate staff so that we can track and report each and every incident that could cause harm,” said Kathy Tanner, director of Quality “Our culture is such that everyone has a role to play, and we all can be alert and responsive in addressing patient safety issues.”

The balloon pump helps a patient by increasing the amount of oxygen to the heart, while decreasing the workload on the heart. It can be used from a couple hours to several days during or after a heart attack, coronary bypass surgery or angiolplasty to open a blocked artery.

Those caring for the patient in the intensive care unit, Becky Higgins, R.N., and Julie Ellis, A.N.P., responded quickly to the event. They unplugged the pump from the wall outlet, placed the machine on stand-by and called a fire alarm. A new machine was ordered and the patient was connected, but not before the patient’s blood pressure had dropped after being off the pump for several minutes.

“The report I entered was based on Becky’s Quality Alert,” said O’Neill, talking about TMC’s electronic tracking device, “which in turn contributed to a significant patient safety action!”

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Tucson Medical Center | 5301 E. Grant Road | Tucson, Arizona 85712 | (520) 327-5461
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