FDA Warns on Sorin Heater-Cooler System
The FDA updated health-care providers that Sorin’s 3T Heater-Cooler System could be contaminated with M. chimaera if purchased before September 2014.
The agency warns that there may be a higher risk of infection associated with surgeries that introduced a prosthetic product or material when the 3T device was used.
Sorin issued Class II recalls for the device in July 2015 and March 2016.
In December 2015, the FDA issued a warning letter to Sorin Group Deutschland GmbH for its 3T Heater-Cooler System after inspections conducted at facilities in Munchen, Germany and Arvada, Colorado revealed significant issues, including quality system and premarket clearance violations ().
The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee is scheduled to meet in early June to discuss recommendations for sampling, notification, patient follow-up and monitoring of the 3T and other heater-cooler devices.
Read the FDA Safety Communication here: www.fdanews.com/06-02-16-Sorin3THeaterCoolerSafetyCommunication.pdf.
FDA Classifies Hummi Recall as Class I
Hummingbird’s recall of Hummi Micro-Draw Blood Transfer device has been classified as Class I due to risks associated with potential disconnection, which can lead to blood or fluid leakage.
Hummi Micro-Draw is used to collect blood samples from infants, including premature infants. Serious adverse effects are associated with blood or fluid loss, including death.
The blood transfer systems were manufactured from June 29, 2015, to Dec. 2, 2015, and distributed from Oct. 26, 2015, to Nov. 18, 2015. A total of 37,750 units were distributed to , , and .
Hummingbird Med Devices has notified hospitals of this recall and recommended they not use blood transfer devices affected by the recall.
Imaging Agent Netspot Nabs FDA Approval
The FDA has approved Netspot, a radioactive diagnostic imaging agent for use in PET imaging.
The first kit for preparing gallium Ga 68 dotatate injection, Netspot is used to locate and assess tumors in adult and pediatric patients with somatostatin receptor positive neuroendocrine tumors (NETs).
Advanced Accelerator Applications plans to market the agent in the U.S. as soon as possible and will commercialize the product in two forms: as a kit for reconstitution using a Ga 68 generator and as a ready-to-use dose.
Granted priority review by the FDA, approval is based on results from three studies of the product, confirming the usefulness of Ga 68 dotatate images in finding the location of the neuroendocrine tumors.