Edwards Lifesciences Aquarius Manual
Pre-owned Edwards Lifesciences Aquarius Haemofiltration Machine, manufactured in 2009 and in excellent condition. Several units available - please enquire for details. Manuals and service history available upon request. Edwards Lifesciences Aquarius Manual Ebook Edwards Lifesciences Aquarius Manual currently available at bestpoint-project.eu for review only, if you need complete ebook Edwards.
Device Aquarius haemofiltration machine. Software versions 3.52, 4.01.11, 4.01.12 and 6.01. Manufactured by Edwards Lifesciences Ltd. Aquarius haemofiltration machines were manufactured by Edwards Lifesciences, but are now supported by Baxter Healthcare, which owns the Aquarius machines business. The software version is displayed on screen when the machine is turned on to start the system safety test.
Problem This Alert provides an update on actions taken by Edwards Lifesciences, as advised in MDA/2009/012. Software versions 3.52, 4.01.11 and 4.01.12 These machines will not have their software upgraded as previously intended. An ongoing training package, a warning sticker and laminated instruction sheet will be provided for each machine. Software version 6.01.
Edwards Life Sciences Aquarius Manual
These machines are due to have their software upgraded as previously advised. Edwards Lifesciences is unable to confirm when the updated software will be available for implementation. In the meantime, Edwards Lifesciences will provide an interim training package as described for the above software versions.
Was issued in February 2009 supporting the issued by Edwards Lifesciences that provided advice on two problems (problems 1 and 2 listed below). A further covering another problem (problem 3 below) was published in March 2009. Following on from these Field Safety Notices and the Medical Device Alert, Edwards Lifesciences updated its corrective actions for the problems as detailed below. Problem 1 The operating manual incorrectly describes how the filtrate line should be connected for haemoperfusion. In addition, for Aquarius software versions 4.01.11 and 4.01.12, these incorrect connection instructions are displayed on the ‘Help Screen’.
Inadequate therapy will occur if these inaccurate instructions are followed. Solution An errata sheet, with the correct set-up instructions, has been provided by Edwards Lifesciences for insertion into the operating manual. Problem 2 If users repeatedly override fluid balance alarms without resolving the cause of the alarm it is possible to remove too little or too much fluid from the patient. Solution Warning stickers and laminated instruction sheets have been issued by Edwards Lifesciences for placing on all machines. For software versions 3.52, 4.01.11 and 4.01.12, a training programme will be provided to address this issue. For software version 6.01 a training programme will also be implemented as an interim measure. A ‘Total Fluid Loss Management’ software upgrade, which will automatically correct fluid discrepancies following a balance alarm, will be installed in due course.
Edwards Life Sciences Aquarius Manual Material Spreader
Problem 3 Following a complaint, Edwards Lifesciences has identified specific programming settings that can result in excess filtrate being removed from the patient. This can occur if the following pump flow rates are set:. within the range 0 ml/h to 110 ml/h for the dialysate/pre-dilution substitution pump (pump designation will depend on the treatment modality selected). 0 ml/h for the post dilution pump.
The excess filtrate removal can occur for any blood flow rate and any treatment modality. This information supersedes the advice contained in the Field Safety Notice issued by Edwards Lifesciences (‘Substitution Fluid Non-conformance’, dated 30 March 2009), which previously stated not to use the parameters ‘100 ml/h or 110 ml/h dialysate/pre-dilution substitution pump’. Solution Warning stickers and laminated instruction sheets have been issued by Edwards Lifesciences for placing on all machines with software versions 3.52, 4.01.11 and 4.01.12. Software version 6.01 will be upgraded to address this issue. In the interim period, warning stickers and laminated instructions will also be placed on machines with version 6.01 of the software. Training will be provided for all software versions.
Action All users should ensure that:. the warning sticker and laminated instruction sheet are placed on all of these machines.
users are reminded to check causes for balance alarms before overriding them. end users are familiarised with the information in the previously issued errata sheet, which should be added to the Operating Manual. Software version 3.52, 4.01.11 and 4.01.12 users should ensure that:. Edwards Lifesciences has made contact and agreed a date for training. Software version 6.01 users should ensure that whilst waiting for upgraded software to be implemented:.
Edwards Lifesciences has made contact to arrange and agree a date for interim training. Distribution This MDA has been distributed to:. NHS trusts in England (Chief Executives). Care Quality Commission (CQC) (Headquarters). HSC trusts in Northern Ireland (Chief Executives).
NHS boards in Scotland (Chief Executives). NHS boards and trusts in Wales (Chief Executives) Onward distribution Please bring this notice to the attention of all who need to know or be aware of it.