It was reported that during a transport flight to a referring facility, the healthcare provider turned on the medfusion pump 4000 to prepare a fentanyl drip infusion.The medfusion pump screen stated the following: "confirm system update." the operator could not preform the update as they were no longer within wifi proximity of the hospital.There was no option to bypass from the screen that was displayed.The operator turned off the pump and then restarted it to only have the medfusion pump display the same "confirm system update" message.This time the operator tried to do the update, but the screen continued to state, "updating system." from the "update system" screen the operator only had the following options: update or biomed.As the operator was still in flight to the referring facility, they could not reach the other medfusion pump 4000, so they decide to use the medfusion pump 3500 that was only reserved for epi infusions.When the operator later reached the facility, they were able to reach the secondary medfusion pump 4000, but it too required an update.Additional information was requested but has not yet been received.Should additional relevant details become available, a supplemental report will be submitted.
|
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Device evaluation this report addresses the message on the pump screen of confirm system update.No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the serial number was unknown.The user's reported problem of not being able to update the pump when not within their facilities wi-fi signal is consistent with how the pump is designed to operate.
|