Medrad® Continuum® MR Infusion System
The Medrad® Continuum® MR Infusion System (Continuum) is no longer available for purchase
This product is currently subject to two recalls. In April 2014, Bayer initiated a new safety recall associated with certain Continuum systems only. Bayer is recalling brackets used to mount the Continuum pump on the IV pole distributed with non-wireless versions of Continuum prior to March 2008. These brackets are being recalled because of a potential safety risk in the MRI environment associated with locking pins, which may become damaged and not restrain the pump from being attracted to the MRI magnet. For customers with impacted brackets, Bayer has combined the communication regarding the bracket recall and the product removal program, so that customers have the full scope of information associated with actions to take on their Continuum system in one communication. Bayer distributed information on April 30, 2014. Each customer received:
- Letter outlining the removal program and bracket recall, if applicable
- Customer-specific information regarding equipment to be returned to receive pro-rated refund
- Disassembly instructions
- Bracket recall information as applicable. Including information regarding near-term continued use for critical medical needs sites using disposable infusion sets with Continuum at an interim flow rate
- Forms to be completed and returned to Bayer
- If you are a current Continuum customer and need information, or did not receive your information please click here
- In the spring of 2012, Bayer initiated a recall due to material variations in the tubing used in the Continuum infusions sets that resulted in flow-rate accuracy performance issues when used in conjunction with the Continuum pump. Bayer’s top priorities are patient safety and serving our customers. No patient injuries were reported as a result of this issue
Bayer HealthCare is initiating a product removal. This is a voluntary decision, driven by technical, regulatory, and manufacturing considerations and a desire to resolve the ongoing recall situation for our customers.
As Bayer completes local regulatory notifications, and ensures that its removal program meets country legal and regulatory guidelines, the company will inform Continuum customers about the removal program process directly or, where applicable, through its local distributor. To ensure that sites have sufficient time to identify an alternative solution to their fluid delivery needs in the Magnetic Resonance Imaging suite, Bayer intends to complete the removal program no later than June 30, 2015. In some countries, based on local business practices, this may occur sooner. Until such time as the product is removed from the local market, Bayer will continue to offer allocated infusion sets and pump preventive maintenance to customers currently receiving sets for use with Continuum at the interim maximum flow rate of 500 mL/hr.
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Continuum customers in other countries should contact their local Bayer affiliate or Continuum distributor for information.