The U.S. Food and Drug Administration (FDA) is pressing for CareFusion to discontinue sells of its anesthesia breathing circuit, the Denver ascites shunt and the Denver precutaneous access kit (PAK) with ascites shunt, citing unapproved changes that were made to the device and quality control problems during the manufacturing process.
Details of the CareFusion Warning Letter
According to MassDevice, the June 6 letters calls on CareFusion to “immediately cease activities that result in the misbranding or adulteration” of the anesthesia circuit and to halt the “commercial distribution of these devices.”
During previous inspections, the FDA noted that CareFusion had made multiple changes to the materials used in the Denver ascites shunt and Denver PAK with ascites shunts, as well as to the manufacturing process for the Denver ascites shunt and Denver PAK with ascites shunts without seeking the FDA’s approval.
According to the federal regulator, changes in the materials on the Y-connector used in the device were made without studies and research over possible biological effects. Further, the regulator notes that such changes required a new 510(k) form, but CareFusion failed to file such a request.
The letter goes on, stating that the changes made by CareFusion could have impacted the safety and effectiveness of the device and that the company failed to take measures in response to complaints involving the device not meeting specifications.
FDA Cites 32 Complaints in Connection With Denver Devices
The FDA claims that CareFusion has been aware of a potential defect in the Denver ascites shunt and Denver PAK with ascites shunts since August 2011 but has failed to take the necessary measures to address the complaints.
The regulatory agency contends that CareFusion has received 32 complaints regarding particulate matter and debris and that 10 of the complaints included the language “a review of complaint data identified a previous complaint with the similar failure modure.”
The FDA has announced that it will be re-inspecting CareFusion to ensure that necessary improvements are being made.