Aquarius haemofiltration machine 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

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. 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.MDA/2009/012 was issued in February 2009 supporting the Field Safety Notice (dated Nov 2008) issued by Edwards Lifesciences that provided advice on two problems (problems 1 and 2 listed below). A further Field Safety Notice 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.
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.
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.
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’.