Full article reprinted from "The Gray Sheet" - August 11, 2008
Find out what Zurich-based Levitronix is doing with the help of the FDA to better understand the root cause of two adverse events that led to a Class I recall of its CentriMag extracorporeal blood pumping system, along with the CentriMag primary and back-up consoles.
Full article reprinted from "The Gray Sheet" - August 11, 2008
With the help of FDA, Zurich-based Levitronix continues testing to better understand the root cause of two adverse events that led to a Class I recall of its CentriMag extracorporeal blood pumping system, along with the CentriMag primary and back-up consoles.
In a letter dated July 24 that updates a notice from March 17, 2008, the company warns cardiothoracic surgeons against using the CentriMag pump in conjunction with Valleylab's Force FX-C or SSE2L electrosurgery devices.
According to CEO Kurt Dasse, the company had FDA review its original March letter. At that point, FDA told Levitronix the letter served as a recall.
"This process was initiated by Levitronix contacting FDA," Dasse said, and "we are working closely with FDA."
The recall pertains to about 867 units worldwide. Dasse noted that European authorities know of the issue but have not required any corrective action.
The firm does not expect the recall to damage its financial status, Dasse said. Levitronix's primary competitor in the blood pumping space is Abiomed.
Electromagnetic Interference At Issue
Earlier this year, the company drafted a letter to inform its distributors around the world that CentriMag had been associated with two adverse events, one in Argentina and another in the U.K., involving electromagnetic interference that led to the sounding of an alarm and device shut-down.
The CentriMag blood pumping system is designed to take over circulatory function for patients during cardiac and other surgeries. Electrosurgery devices such as the ones from Valleylab, a Tyco division based in Boulder, Colo., are used to stop bleeding at the surgical site.
Electromagnetic interference can occur "with specific units in specific modes" when a current from the electrosurgery device travels through the patient's bloodstream and interferes with the CentriMag, Dasse noted, adding that the company warns against operating the unit in the monopolar mode.
The CentriMag was originally designed to set off an alarm and shut itself off when it detects certain types of noise or electromagnetic interference.
"If this does require a design change, we know what to do," Dasse said.
Levitronix had certain safety measures in place. In the event a blood pumping system shuts down, hospitals can reboot the system, "and the problem goes away," Dasse explained, adding that hospitals are instructed to keep a back-up unit in place during surgery. "There are multiple safety measures open."
Labs at Levitronix headquarters and at independent facilities in Germany over the past few weeks have been testing the CentriMag product with other manufacturers' electrosurgery devices to check for possible interference.
Levitronix has been able to reproduce the electromagnetic interference problem in tests with Valleylab equipment. "We have a very good idea" about what led to system shut-downs in clinical use, Dasse said, but he added it would be inappropriate to draw conclusions before testing is finished.
On Aug. 5, Dasse said he expected testing could be completed "within days."
Devices Remain In The Field
In an interview with "The Gray Sheet," Dasse was quick to note that there have been no injuries or deaths as a result of the adverse events, and that the events occurred in only two of the more than 3,000 patients who have had surgeries using the device since 2003, when it entered clinical use.
In June, FDA told Levitronix the agency considered the matter a Class I recall - the agency's most serious recall classification, reserved for situations in which FDA believes the product poses a reasonable probability of serious injury or death - and suggested the company send out new letters, Dasse said.
Levitronix is collecting responses from hospitals that have received the recall letters. The company has not asked customers to return the devices. It is a Class I recall not because any deaths or serious injuries have occurred, Dasse said. "It's the potential."
- Monica Hogan
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