FDA warns radiation therapy company about software errors
The Everett, Wash.-based Northwest, which is now CIVCO Medical Solutions, received three other complaints in 2006 about misadministration of radiation to cancer patients due to problems with the software.
The information in the complaints suggests the software could cause or contribute to a serious injury to a patient, the letter said. A corrective and preventive action and complaint from 2005 described an omission error upon manual data reentry for a patient receiving radiation treatment.
The radiation therapy was not at the correct anatomical site due to a software error, according to the FDA. The error caused a program to freeze and then multiply location values after the software was rebooted, the letter said.
The company failed to submit medical device reports to the FDA within 30 days of receiving information that suggested one of its devices had malfunctioned and would likely contribute to a death or serious injury if the malfunction recurred, according to the letter. Reports also were not submitted to the FDA within 10 days of initiating corrections or removals for seven software patches, the agency said.
CIVCO Medical of Kalona, Iowa, sent several responses to the FDA’s Form 483 citations in 2007, but the agency said its responses were inadequate, according to the letter.
The company could not be reached by Health Imaging News for an update on actions it has taken in response to the FDA letter.