International Perfusion Association

Day: May 12, 2024

FDA Warning

Safety and Quality Concerns with Getinge Cardiovascular Devices – Letter to Health Care Providers

On May 8, 2024, the FDA warned healthcare providers about ongoing safety concerns with Getinge/Maquet cardiovascular devices, specifically the Cardiosave Hybrid and Rescue IABP devices and the Cardiohelp system with HLS Sets. Despite corrective actions, these devices pose significant risks. The FDA advises transitioning to alternatives and reporting adverse events. Multiple recalls and serious injury reports have highlighted persistent issues with these devices, leading to enhanced FDA oversight.

READ MORE
Myocardial Injury

Hybrid Feature Selection in a Machine Learning Predictive Model for Perioperative Myocardial Injury in Noncoronary Cardiac Surgery with Cardiopulmonary Bypass

This study developed a predictive model for perioperative myocardial injury (PMI) using hybrid feature selection (FS) methods in patients undergoing noncoronary cardiac surgery with cardiopulmonary bypass (CPB). Conducted at Fuwai Hospital, China, the retrospective study included 1130 patients, with an overall PMI incidence of 20.3%. Various machine learning models were evaluated, with the Naïve Bayes model achieving the highest AUC. The study highlighted the importance of factors like prolonged CPB, aortic clamp time, and preoperative low platelet count in predicting PMI risk.

READ MORE