It is possibly a good time to give some previously unavailable information regarding the on going rhetoric regarding the Baxter Colleague Pump's inaccuracy or otherwise.
Baxter recommends their oft-disputed gravimetric test method, on which others and I have already debated. Our recent testing of some 40 plus Colleagues, with infusion rate accuracy errors, were identified using the Bio-Tec IDA4 plus.
To ensure that the accuracy of these tests would be indisputable, we developed our own PC based gravimetric test unit for volumetric infusion devices. Results unsurprisingly mirrored those found by the IDA4 plus. Visits by representatives of Baxter Service U.K. did not disagree with our findings and the faulty PHM's, where identified, were replaced either them or by myself.
Now to come to the reason for my posting; on 30 January 2003 Graham, member # 548, said he had that day received a letter from Baxter regarding the testing of the Colleague Pump. The information given was that there were limitations to the IDA4 plus, due to the Colleague's Shuttle Motor technology, and that tests should be done using balance scales to a certain specification.
The letter also stated that the IDA had not been evaluated in the UK or any other country and should only be used as a guide.
I wish to advise those of you who might have reservations of the suitability of the IDA4+, that this statement by Baxter is somewhat disingenuous, as the following will I hope show.
In the USA the FDA inspected the IDA4+ and gave it a 510(k) listing number; # K97609. This is not issued lightly as;
510(k) Number K973609
Device Name: IDA-4, Infusion Device Analyser
Indications For Use;
This IDA-4 is designed to be used by manufacturers, BioMedical engineering departments in Hospital and third party service organisations to verify the accurate performance of infusion devices. It is not intended to be used as an infusion device calibrator. A wide range of infusion devices can be analysed including: drop counting, peristaltic, and volumetric types. Steady and non-steady flow rate pumps can be analysed. The device is designed to operate using water or saline only. It incorporates an RS232 serial port for computer control/data output and a Centronics type parallel printer port.
Specifications;
One to four test channels each with independent operation.
Average Flow Rate;
Range: 0.5 to 1000 ml/hr
Accuracy; + /- 1% of reading +/- 1 Least Significant Digit (LSD) for rates of 50 – 100 mL/hr
for delivery volumes over 20 mL. Otherwise +/- 2% of reading +/- 1 LSD after delivery of
5 mL. Specifications are with water at 15 to 25C.
Instantaneous flow rate is read from a device display graph or PC screen.
Delivered Volume:
Range 0 – 9999 mL
Accuracy: +/- 1% of reading +/- 1 Least Significant Digit (LSD) for rates of 50 – 100 mL/hr
for delivery volumes over 20 mL. Otherwise +/- 2% of reading +/- 1 LSD after delivery of
5 mL. Specifications are with water at 15 to 25C.
Flow and Accuracy Under Back Pressure:
Same accuracies as those listed above.
Range – 100 mmHg to + 300 mmHg.
This is signed at the bottom, “ Concurrence of CDRH, Office of Device Evaluation (ODE)”
510(k) Number K973609
For “ Over The Counter Use”
In reality the IDA4+ has been sold, and works, world wide on an extensive range and variety of manufacturer's infusion devices with no problems identified, is the Baxter Colleague therefore unique with its purported problems? Baxter in Ireland is believed to have IDA's and experiencing no difficulties.
It is believed that Ultramedic, an ISO 9000 Registered company for many years, is the UK manufacturer for the IDA range, who did their own tests with a Colleague Pump with results as follows:
A Calibrated 50mL burette was connected at a suitable height to a Colleague Pump, set at a Rate of 100 mL/hr; with Volume set to 20 mL. The output of this pump was fed into the IDA4+, on completion the Colleague said 20 mL, the burette however had delivered only 18.3mL and the IDA4 said 18.2mL.
I leave it to you my friends to make your own conclusions. But we are very supportive of the IDA and all manufacturers' devices checked with it cause us no concerns. It is also interesting to note that Bio-Tek is now part of the Fluke BioMedical Group and as such will be marketed under their name. Who among you has problems with FLUKE devices?
In closing it is to be noted that the FDA visited Ultramedic to evaluate them, the answer my friends is in the 510(k).
I rest my case! As usual all views expressed are personal.
Ian-C
** To whom much is given – much will be expected **
