Outpatient Surgery magazine reports that the FDA has obtained more reports in the past six months of death and injuries related to the Neptune fluid waste management systems. Although the precise cause of the problems is not yet identified, investigators speculate that incorrect application of the high-flow, high-suction vacuum system and improper user training are the primary issues. The FDA has recommended that all healthcare providers stop using the Neptune 1 Silver and Neptune 2 Ultra systems. To continue using the systems under a Certificate of Medical Necessity, all users must be adequately trained and utilize a pre-use checklist.
Stryker Instruments updated its recall on February 20 to remind providers to stop using the Neptune 1 Silver and Neptune 2 Ultra. Stryker has recalled all serial numbers of the Neptune 1 Gold Rover, Neptune 1 Silver Rover, Neptune 1 Bronze Rover and Neptune 2 Rover. The Neptune 1 Silver and Neptune 2 Silver have never been cleared for U.S. sale.
The Neptune systems are used to collect and dispose of surgical fluid waste in operating rooms of surgical facilities. The system consists of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied with the use of a docking station.
The FDA reports that, when used incorrectly, the waste management systems can cause hemorrhaging and damage to soft tissues, muscles and vital organs and can lead to serious injury and death.
Virginia Buchanan is a shareholder at Levin, Papantonio. She has served on the Board of Directions of the Florida Bar Foundation and has been Treasurer of ABOTA, Chairperson of the Civil Process Server Grievance Committee and has been a member of the Chief Judge’s Council on Children. She currently is a member of the Women’s Caucus of the Florida Justice Association.
