Line tubing may separate from the patient line connectors, and can result in serious adverse health consequences. Medtronic Neurosurgery has recalled the Duet External Drainage and Monitoring System (EDMS) because the line tubing may separate from the patient line connectors, and can result in serious adverse health consequences, according to the Food and Drug Administration (FDA).
The Medtronic Duet External Drainage and Monitoring System (EDMS) externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP). The device is intended for use only when trained personnel are present to supervise monitoring and drainage 24-hours a day.
Medtronic reports that the patient line is more likely to disconnect during frequent handling, such as when the patient requires frequent injections or sampling. The device’s failure can result in air within the patient’s skull (pneumocephalus), infection (such as meningitis, ventriculitis, encephalitis) and over or under drainage of cerebro-spinal fluid. The firm, to date, has not received any reports of deaths.
This is a Class I recall, the FDA’s most serious recall category
This is a Class I recall, the FDA’s most serious recall category, reserved for situations where use of the device can result in serious adverse health consequences, or even death.
The affected products were manufactured from March 15, 2013 through February 28, 2014 and distributed from April 10, 2013 through May 19, 2014. A complete listing of affected lot numbers can be found on the FDA web site
Medtronic advises customers to stop using the recalled product and return all unused devices to Medtronic Neurosurgery. If affected products are in use, the caregiver should verify that all connections are secure and leak-free. For questions about this recall, customers may contact Medtronic’s Director of Quality at 1.805.571.8725, Monday – Friday, 8:00 a.m. – 5:00 p.m., Pacific Time.