Baxter warns of problems with infusion pumps.

Baxter issued an Urgent Device Correction to inform caregivers of an issue concerning the triple channel Colleague infusion pumps.

Baxter has recently received six reports from three customers in Canada that Colleague triple channel infusion pumps stopped infusing during specific use conditions.

In each instance, the pump issued an audible and visual alert notification as designed, displayed a buffer overflow error code (16:310:867:0002) and stopped infusing. Of the reports received by Baxter, these interruptions occurred when the buffer memory capacity of the device was exceeded.

The company's analysis has determined that the overall probability of buffer overflow is extremely unlikely. However, in a controlled laboratory environment, they were able to reproduce buffer overflow with a significantly higher probability of occurrence when all three channels are simultaneously infusing fluid with both the dose mode and flow check enabled and while either a dose mode titration is being performed or an alert is being resolved.

Baxter is currently validating a software solution to this issue and will provide it to customers once it has been completed.

Serious adverse consequences could occur if the pump stops infusing. Given this potential, Baxter requests that, in the interim, users immediately consider one of the following options to mitigate the occurrence of this interruption of therapy:

* Utilize only two channels of the triple channel pump. If necessary, use a single channel device in the place of the third channel. Please note that, although there is no way to permanently disable the third channel on the Colleague infusion pump, Baxter can provide options to prohibit loading and use of the third channel should they be required.

* Ensure a back-up single channel device is available in clinical situations when therapy is deemed to be complex (i.e. All three channels infusing, dose mode enabled and flow check enabled)

* Do not enable the "dose mode" feature on Colleague infusion pumps if it has not been previously enabled on the device.

Single channel pumps are not affected by this issue and may be used as alternatives if available. If the mitigations outlined above are not acceptable, Baxter said that subject to single channel pump availability, it will provide single channel devices to be utilized as back up devices, as required.