CMS Changes in Reimbursement for ECMO Procedures
The Centers for Medicare and Medicaid Services (CMS) implemented changes for ECMO procedures in the Medical Severity-Diagnosis Related Group (MS-DRG) on October 1, 2018.
Hydrogen Peroxide Monitoring and Design Upgrade Customer Letter
The purpose of this letter is to advise you that LivaNova Deutschland GmbH (“LivaNova” or “the Company”) is executing a voluntary medical device correction for the 3T Heater-Cooler Systems (“3T”). This letter describes immediate action to be taken by you.
FIELD SAFETY NOTICE UPDATE Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices
Attention: Hygiene Specialists, Cardiac Surgery Operating Room Responsible, Risk/ Safety Managers, Distributors, Clinicians, Perfusionists and other users of these devices
Reemergence of Mycobacterium chimaera in Heater–Cooler Units despite Intensified Cleaning and Disinfection Protocol
Invasive Mycobacterium chimaera infections after open-heart surgery have been reported internationally.
Quest Medical, Inc. Issues Recall of MPS® Delivery Set
On October 28, 2015, Quest Medical, Inc. initiated a nationwide recall of Myocardial Protection System (MPS) Delivery Sets, Models 5001102, 5001102-AS, and 7001102 of specified lots. The product(s) have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss.
Platelet Rich Plasma and Knee Surgery
In the last fifteen years, the field of regenerative medicine is witnessing a boost of autologous blood-derived platelet rich plasma products (PRPs) application to effectively mimic and accelerate the tissue healing process.
Maquet Medical Systems, Tiger Paw System II – May Cause Tears and Bleeding in Heart Tissue
The reason for recall is the incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding. The use of this recalled device may cause serious adverse health consequences, including death.
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18
Fatal Air Embolism during Cardiopulmonary Bypass: Analysis of an Incident and Prevention Measures
We present a case of a patient who suffered an air embolism
A Cluster of Mycobacterium wolinskyi Surgical Site Infections at an Academic Medical Center
Observational investigation revealed a cold-air blaster exclusive to operating room A as well a microbially contaminated, self-contained water source used in heart-lung machines
Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System
IABP brand names for a potential mechanical failure of the fan assembly associated with the power supply.
Thoratec Corporation Issues Worldwide Urgent Medical Device Correction Letter to Update its Labeling Regarding the Use of the HeartMate II® LVAS Pocket System Controller
This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller.