A portable compressor for artificial hearts may have contributed to the death of a 57-year-old California man. The U.S. Food and Drug Administration is currently investigating multiple reports regarding problems with the medical device, according to Kaiser Health News.
The Freedom portable driver, manufactured by Tucson, Ariz.-headquartered SynCardia Systems, powers artificial hearts and allows hospitalized patients to return home even if they are ill or waiting for a heart transplant.
The man who died was a patient at Cedars-Sinai Medical Center in Los Angeles. Hospital officials believe the compressor may have failed and lead to the man's death and discontinued use of the device for the time being. Two other patients at the hospital were readmitted after being sent home with the Freedom portable driver.
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Deborah Kotz, a spokeswoman for the FDA, told Kaiser Health News hospitals other than Cedars-Sinai have reported problems with the device, although she did not disclose which hospitals encountered issues.
According to Kaiser Health News, in August 2015, SynCardia discovered an issue with a certain component of their drivers and voluntarily recalled 56 worldwide, including 29 in the U.S. The following month, the FDA issued a recall of the same 29 devices, warning that certain drivers could suddenly fail.
SynCardia CEO Michael Garippa told Kaiser Health News the issue with the 2015 drivers was caused by a supplier who inserted a screw in the wrong part of the gear box.
Regarding the death of the Cedars-Sinai patient, Mr. Garippa said, "It is unfortunate, but that particular patient was on our device for over 500 days, and we extended the life of that patient, who was extremely ill and near death at the time of his artificial heart implant."
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