EBME Forums Forums Management Medical Equipment Management Baxter Colleague

Hi All,
I'm new to this forum, but I gather you are talking about MDA/2005/050 or similar?

We found one pump with an offending error code through our equipment management software (the error had manifested some time ago) We have also enlisted Baxter to check our pumps (>100) and so far they have not found any offending error codes.

However - as I understand it - the pumps only have an 'event-log' rather than an 'error-log'. The event log records every key-push and has a limited memory. In the case of pumps that were in frequent use - we found that the event log could only hold about 1 month's worth of records. What if the error occured more than a month ago?

We brought this to the attention of Baxter and suggested that the inclusion of an 'error-log' might be a good idea in future fixes ? Does anyone else agree? Any comments ?

Further to the rather worrying link from above a I have been made aware of a number of other issues raised on the ECRI website relating to the Baxter colleague. Unfortunately you need to be a member of ECRI to view. www.ecri.org.uk Hope this helps

I think it's clear from postings by engineers on this website that there are/have been concerns from a technical standpoint regarding the Colleague volumetric infusion pump. What surprises me is that this must impact on the use of the pump hence operators must be having problems with them, e.g. a high rate of failures/errors (not necessarily those given in the recent recall). There must be under-reporting or a failure to feedback operators' concerns to risk coordinators, supplies departments and the MHRA if the process relies almost entirely on technicians and engineers to inform those who continue to purchase such devices that there's possibly something not quite right with it, rather than those using it.

Hi, I posted this last week, as we follow a mainly American system I had this mail shot from a co-functional in the US of A

https://www.ebme.co.uk/ubb/ultimatebb.php/topic/4/686.html

Sorry if its old information but I cannot find a ref anywhere here.

LIII

The point I'm making is that in the UK we have been relying on Engineers/Technicians to highlight problems on sites such as this for a couple of years and nothing seems to have prompted much of a response or recall in the UK. Operators and risk assessors have a responsibility to feedback problems to the MHRA as well.

The errors that Baxter describes in the recent recall are not the common ones that I see on a regular basis (that occur during use and prevent the pump being used or cause it to fail on the patient) and there's nothing about the tendency of these devices to under-infuse (requiring replacement of major pump components) or, in my opinion, the premature failure of service-exchange pump head modules as supplied in the UK. What's being done about these other issues I wonder?

The failure of batteries/power-related errors is one that needs more urgent attention in my view and needs to have a higher profile. Newer firmware revisions and enhanced battery harnesses are possibly the solution but I don't see this being touted in worldwide recalls.

I'd have thought the MHRA would have received feedback from operators describing issues with Baxter Colleagues. Perhaps the issues that I have, personally, are only local ones that others, including operators and risk assessors, who sift through the incident reports, are not experiencing. If so then my concerns are obviously misplaced.

FDA update:
http://biz.yahoo.com/ap/051014/baxter_recall.html?.v=2

Thanks Chris - I wasn't aware of that second news story. My questions above have been answered.

From my experience with the Baxter Colleague the main problems are those associated with batteries that fail in use - they split, overheat and sometimes, in fact regularly, leak into the pump (see previous links from way back, elsewhere in the forum). The LA battery used in these pumps is notoriously unreliable in my experience - it also failed regularly in a similar fashion in another company's pulse oximeter products I used to work on. I don't know whether poor design is a contributory factor or not but it's possible.

Errors that I assume are associated with power failure during use, either on battery or on mains are apparent and a regular occurrence. On older models with early software this can result in the sets being trapped in devices even when the pump is still functioning when the giving-set mechanism resets.

Under these circumstances, when devices fail, operators panic, can't remove giving sets that are connected to patients, can't turn devices off (if they're alarming) unless they manually reset the mechanism (which is not necessarily obvious if there are no prompts or guidance available from the pump) or turn them back on again (if they power-down with the mechanism closed) with the set still within the pump. That's why we get cases where sets have been cut and fluids get inside pumps when they fail.

The early-revisions of battery harnesses allow currents to circulate between LA batteries that may have different levels of charge (due to mismatch in capacity and different battery terminal voltages I assume) - thus, in dual battery models, faulty batteries can deplete or compromise batteries that are Ok. Potentially high currents (up to the 4A inline fuse limit) can circulate in paralelled batteries until equilibrium is reached, which is poor design, in my opinion.

I'm aware of the availability of replacement battery looms with current-limiting and reverse-protection devices fitted in them and the availability of replacement software to overcome problems with operators handling pump mechanism failures in use. As far as I'm aware Baxter UK are making these looms and software available and have circulated information concerning battery maintenance issues.

This is a device that some "experts" in procurement who work in NHS supplies, EBME and Medical Physics departments have been touting for quite a while I think. Someone hasn't been doing their homework and keeping up with developments, perhaps. I think it's our duty to make our operators aware of the potential issues if the MHRA, risk managers and supplies departments do not.

The Baxter recall, as communicated by the MHRA, doesn't make reference to the battery and pump head mechanism related failures (which I and others I've spoken to consider to be the common causes of failure in use) does it?