Baxter ($BAX) is facing a new set of regulator entanglements related to the infusion pumps that were yanked from the market two years ago because manufacturing issues led to a host of problems.
The company says it was served a subpoena in March by the Securities and Exchange Commission, which wants info "related to the company's accounting treatment, financial reporting and disclosures relating to the remediation and recall of the company's Colleague and Syndeo infusion pumps," MassDevice reports. "The company is fully cooperating with this investigation," it says in a SEC filing.
The FDA ordered 17 recalls over 5 years related to infusion pumps in general. The agency said it received more than 56,000 complaints--many of which involved injuries and even 500 deaths--tied to the pumps, MassDevice reports. The FDA ordered Baxter in May 2010 to pull its pumps because of a "long-standing" failure to correct problems. The furor over the myriad problems led the FDA to tighten regulations on all medical devices.
The FDA warning letter issued in January 2011 suggested some pretty appalling problems at two Baxter plants in Puerto Rico. It says Baxter didn't fully investigate consumer complaints about discolored medication and only recalled the products when the FDA ordered it. "Your investigation concluded that the administering health care professionals (i.e., pharmacist, nurse, or physician) would identify any discoloration and prevent the usage of the drug product. It is unacceptable to rely upon the health care professional to fulfill your Quality Control Unit responsibilities."
- get the MassDevice story
- here's the FDA warning letter