Surgeons, PA’s, RN / CST / NP 1st Assistants,

Anesthesiologistsetc.

All instructions and images were taken

from Stryker’s Neptune Training and

Risk Mitigation Binder per their

consent.

Neptune is a high vacuum/high flow device used in our operating rooms for suction and collection of fluids and waste from surgical fields

In June 2012 Stryker was notified that a Neptune was connected to a passive chest drainage tube postoperatively (clinically known to be a low suction application). Using the Neptune may have resulted in hemorrhage, which lead to death.

The FDA decided that the Neptune was not legally marketed and should be removed from use. Hospitals with limited options could continue to use the Neptune if a Certificate of Medical Necessity was completed and additional training was provided.

Unfortunately, additional reports of serious injuries or deaths have occurred requiring mandatory steps for the continued use of the Neptune. Completing this CBL and its test as well as other elements (pending job type) will ensure St. Joseph’s/Candler compliance with the FDA mandate.

Neptune Recall History

Reference Attached Warning Sign With Each UseDO NOT apply High Flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction (for example, passive chest drainage).

DO NOT use these devices to provide suction to other suction powered accessories, such as Pleur Evac® devices.

DO NOT use these devices with closed wound drainage systems.

DO NOT use this device for post operative use

ALWAYS consider the type of tissue associated with the surgical procedure BEFORE using this system.

ENSURE that in low level suction applications that the appropriate suction device is used. IT IS RECOMMENDED that an alternate source of low level suction be available for low level suction applications (for example, suctioning an airway or near vital anatomical structures).

ENSURE the user has a clear understanding of the units of measure that are displayed. It is recommended that you set your unit to mm-Hg.

ENSURE the level of suction has been checked and is appropriate for the planned procedure

ENSURE the device control panel can be clearly seen and is not covered by drapes or other objects.

ENSURE that all users of this Neptune device are adequately trained on the appropriate use of the device and are fully aware of the applications for which it is intended to be used and the risks of using it improperly.

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Failure To Comply Could Result In Injury

The following risk mitigation measures should be taken each time you use the Neptune waste management system:

Do not use Neptune 2 in low suction applications that require vacuum levels below 50 mm-Hg, 2.0 in-Hg, or 7.0 kPa as this could result in injury to vital anatomical structures, and/or hemorrhage, both of which may result in serious injury and/or death.

The Neptune 2 vacuum limit is adjustable from 50 – 530 mm-Hg, 2.0 – 21.0 in-Hg, or 7.0 – 71.0 kPa.

The Neptune 2 has a maximum vacuum level of 530 mm-Hg, 21.0 in-Hg, or 71.0 kPa, and is therefore considered to be a high vacuum suction device.

Suction/Vacuum Ranges

Stryker has been working with the FDA on requirements for ensuring all users are trained on the proper use of the device. We have developed a 9-point checklist (circulating RN will document in the OR record) that the Circulating Nurse must complete before every procedure using the Neptune device.

Please keep in mind that Stryker and the FDA will be performing audits on these records to ensure the Pre-Use Checklist is being used and that all users have been trained on the device. Failure to use this checklist prior to each procedure is grounds for revoking the Certificate of Medical Necessity signed by your facility.

Pre-Use Checklist

Elements in Checklist

Elements in Checklist

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