A suction system for collecting surgical waste apparently killed one patient and seriously injured another, prompting its maker to recall it and several related devices, the FDA said.
The recall covers Stryker Instruments’ Neptune 1 Silver and two models of its Neptune 2 Ultra Waste Management Systems. These are high-powered, mobile vacuum devices for disposing of surgical fluid waste in operating rooms and other surgical facilities, and they can also clean the room air of smoke generated from electrocautery and laser surgery.
According to Stryker, the fatality occurred when a customer connected the Neptune 2 system to a patient’s chest drainage tube after surgery. Details of the other, nonfatal injury were not disclosed.
“The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and that the instructions for use on the device did not specifically warn against this action,” the FDA said.
“When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle and vital organ damage that can lead to serious injury and/or death.”
Previously, Stryker had issued revised labeling for these and four other models in the Neptune 1 and Neptune 2 lines. But the FDA determined that the Neptune 1 Silver and Neptune 2 Ultra models also contained modifications that should have been submitted for premarket 510(k) notification, which Stryker had not done.
Despite the violation, the agency said, “the FDA is not currently asking Stryker to remove the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System from the U.S. market due to concerns that removal would likely create immediate market shortages.”
Instead, the regulator is instructing customers with these devices not to use them unless they have no alternative systems for collecting and disposing of surgical fluid wastes.
For customers who find it necessary to continue using the recalled systems, the FDA and Stryker issued a series of detailed instructions and warnings.
For example, they said, customers should verify that they “are using the intended units of measure when setting suction levels,” because the digital readouts can be in inches of mercury, millimeters of mercury, or kilopascals.
Customers were also told to ensure that suction is not set to higher levels than necessary for a given application, and under no circumstances should either device be used for respiratory tract suction.
Under Stryker’s earlier recall, customers who had bought the firm’s Neptune 1 Gold Rover (regular and international), Neptune 1 Bronze, and Neptune 2 Rover Ultra were issued warning labels with many of these revisions.
The FDA emphasized that the new warning does not apply to those products.
Stryker stopped manufacturing the Neptune 1 Silver device in 2009 but still provides support.