Edwards EV1000A User manual

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UPDATE TO URGENT FIELD SAFETY NOTICE
FCA #128
Product: EV1000 clinical platform
Model Numbers: EV1000A, EV1000NI
Serial Numbers: All serial number for models listed
ACTION REQUIRED
<MM DD, YYYY>
<Customer #>
<Contact name or Dept.>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Dear Valued Customer:
This letter is in follow-up to our previous communications regarding EV1000 monitors and the risk
associated with the power supply as communicated earlier.
Edwards is working to address all the root causes, and to implement corrective and preventative
actions as quickly as possible. There are two types of monitors, each with different power supply
configurations and different actions, as described below.
Edwards would like to highlight the importance of:
EV1000A
The EV1000A utilizes the FloTrac sensor and is powered by an external power supply. As
previously noted, it is important that the “brick” of the power supply always be oriented correctly
to avoid the risk of liquid ingress as shown below and according to the equipment operators’
manual.
Correct Orientation
Flag Label

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Based on our previous customer notification, we strongly advise you to be cautious that IV bags
and other fluids need to be positioned away from AC power connector in order to avoid liquid
ingress.
Further actions for EV1000A will include:
Updated customer notification of all potential causes and mitigations, including ensuring the
AC power cord and inlet are kept clean, dry and free of contamination by conductive materials
prior to use.
Visiting your facility to (1) apply a “flag label” to the
AC power cord so that the proper orientation is clearly
marked for the user, and (2) confirm that the area is
clear of potential contaminants.These visits are in
progress and may have already occurred at your
facility.
In the event your staff mistakenly fail to follow the
instruction on the flag label, we are providing a newly-
designed cover for the power supply “brick” to provide
additional protection, eliminating or reducing the
potential for liquid ingress and other potential
contaminants.
Edwards personnel, Technical Service
Administrators or a distributor will contact you to
arrange installation: it can be installed by your
Biomedical Engineering Staff, in accordance with the
guidance that will be provided by Edwards personnel
OR Edwards personnel will visit your facility to apply
the Flag Label and Cover.
Please note that due to the fluid situation of COVID-19, Edwards Personnel will visit
your facility at a later date.
Power Supply with Cover

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EV1000NI
The EV1000NI uses non-invasive ClearSight cuffs as the sensor and is powered through the
Pump component.
Unlike the EV1000 A, the EV1000 NI AC cord inserts horizontally into the unit. Therefore,
orientation is not a factor of liquid ingress. However, in case of excessive liquid exposure, the unit
may short circuit leading to a possible fire hazard due to liquid ingress at the AC cord connection.
This liquid ingress into the AC inlet can result in smoke, sparks, or fire if fluid bags are allowed to
drip on this power inlet.
Edwards is releasing a power cord entry cover for the pump unit in the EV1000 NI system to
reduce the potential for liquid or other conductive contaminants to enter the AC inlet. Edwards
recommends that the power cord not be removed from the power cord entry cover assembly once
first installed to avoid contamination, with exception of activities per your policy for inspection and
cleaning, and in accordance with cleaning instructions in the Operator’s Manual.
While the power cord entry cover helps prevent shorts through liquid ingress, IV bags and other
fluids should still be placed away from electronic connectors to ensure the units
remain dry and free of contaminants.
The actions for EV1000NI include:
Implementation of design changes to EV1000NI, Boot and Bracket, to eliminate or reduce the
potential for liquid ingress and other potential contaminants. Edwards personnel, Technical
Service Administrators or a distributor will contact you to arrange installation: it can be installed
by your Biomedical Engineering Staff, in accordance with the guidance that will be provided
by Edwards personnel OR Edwards personnel will visit your facility to apply the Boot and
Bracket (due to the fluid situation of COVID-19, Edwards Personnel will visit your facility
at a later date).
With Boot & Bracket
Without Boot & Bracket

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If you have an EV1000CS system, which combines the
capabilities of the FloTrac sensors and the ClearSight cuffs,
the system is powered by the pump unit. Please discard
the power supply cord that was provided with the EV1000A,
and use only the power supply on the back of the pump unit.
This notice needs to be passed on to all those who need to be aware within your organization or
to any organization where the potentially affected devices have been transferred.
If you have any questions, please contact Edwards Tech Support at <phone>.
Sincerely,
Linnette Torres
Vice President of Quality, Critical Care
This Update to the Urgent Field Safety Notice has been communicated by Edwards Lifesciences
to the relevant competent authority.
EV1000CS

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UPDATE TO URGENT FIELD SAFETY NOTICE
FCA #128
Product: EV1000 clinical platform
Model Numbers: EV1000A, EV1000NI
Serial Numbers: All serial number for models listed
CUSTOMER ACKNOWLEDGEMENT
<Customer #>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Please follow all instructions below to complete the acknowledgement process.
Complete this acknowledgement form with the following information:
•DO NOT return any product
•Verify your inventory and correct setup of the system
oComplete the table below following the steps: For EV1000A configuration, fill out
with the databox serial number (1) (“EVDXXXXX”) and enter an “X” or “Yes” on
“Flag Label” and “Power Cover Adapter”, or indicate N/A if the equipment already
has any of the components, or if you have no product.
oFor EV1000NI or EV1000CS configuration, fill out with the pump unit serial number
(1) and enter an “X” or “Yes” on “Boot & Bracket”, or indicate N/A if you have no
product.
•E-mail the completed form to Edwards Tech Support at <email>, within 5 days from receipt
of this notification
•Edwards will visit your facilities to implement the corrective and preventive actions
described above.
(1) EV1000A Databox or EVPMP
(pump unit) Serial
Number(s)
Request Flag
Label
Request
Power Cover
Adapter
Request Boot &
Bracket
Name (Print):
Title/Dept.
Telephone Number:
Signature:
Date:
Please return this form via email to Edwards Tech Support at: <email>

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URGENT FIELD SAFETY NOTICE –
FCA #128
EV1000
Model Numbers: EV1000A, EV1000NI
Lot Numbers: All lots for models listed
<MM DD, YYYY>
<Customer #>
<Contact name or Dept.>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Dear Valued Customer:
As part of our strong commitment to quality, we continuously monitor our products throughout
their life cycle to quickly identify and correct any potential issues. We recently became aware of
an issue with Edwards EV1000 clinical platform, and are notifying our customers.
Details on affected devices:
The EV1000 clinical platform is used to optimize fluid management through the use of minimally
invasive or non-invasive monitoring technologies.
The EV1000A system consists of the following components to monitor a patient using minimally
invasive technology:
 Monitor
 Databox
 Power adaptor
The EV1000NI system consists of the following components to monitor a patient using non-
invasive technology:
 Monitor
 Pump Unit
 Pressure Controller
 Heart Reference Sensor (HRS)
Description of the problem:

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Edwards Lifesciences has identified a potential risk, which may occur during the use of the
EV1000 clinical platform with minimally invasive and non-invasive technologies. Edwards
Lifesciences has received a limited number of reports regarding fluid ingress into the AC power
outlet on both the EV1000A power adaptor and the EV1000NI pump unit.
This is a voluntary safety notice regarding the EV1000 clinical platform to reinforce the proper set
up of the external power supply according to the equipment operator manual. Edwards
Lifesciences has been notified about the potential for an electrical short circuit leading to a
possible fire hazard due to liquid ingress. This issue was noticed at the AC cord of an EV1000
clinical platform due to incorrect orientation. Edwards Lifesciences is not removing product
from commercial distribution.
Based on review of previous instances, we strongly advise you to be cautious that IV bags and
other fluids need to be positioned away from AC power connectors in order to avoid liquid
ingress.
For EV1000A clinical platform installations:
We are informing all customers with EV1000A clinical platforms to confirm compliance of
installation configuration with the current requirements documented in the Operator’s Manual
section EV1000 Power Adapter Mounting Bracket.
This notification is a reminder that the EV1000A Operator’s Manual warns about immersion of
the device or its components and warns against letting fluid enter the device (reference is
included in the Warning and Caution section of the Operator’s Manual).
The external power supply for the EV1000A should be installed as illustrated in the Operator’s
Manual (Figure 15-8 EV1000 Power Adapter Bracket and Figure 15-9 EV1000 Power Adapter
Bracket included in the Operator’s Manual) where the AC cord plugs into the power supply,
exactly as shown in the illustrations in the Operators Manual.

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Reference Warnings and Caution Section from Operators Manual
Figure from EV1000A Operators Manual on Power Adapter Orientation
(Figures 15-8 and 15-9)

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See illustration for set up from the wall outlet to power supply at the bottom of power adapter (3)
as per the illustration of figure 15-9.
Please take this opportunity to review the EV1000A clinical platform configurations at your site to
ensure they are configured as instructed in the Operator’s Manual, to minimize the risk of fluid
ingress.
For EV1000NI clinical platform installations:
We’ve received reports where liquid is dripping on to the unit which may lead to an electrical
short circuit leading to a possible fire hazard due to liquid ingress. Unlike the EV1000A, the
EV1000NI AC cord inserts horizontally into the unit. Therefore, orientation is not a factor of liquid
ingress. However, in case of excessive liquid exposure, the unit may short circuit leading to a
possible fire hazard due to liquid ingress at the AC cord.
We strongly advise you to be cautious that IV bags and other fluids need to be positioned away
from AC cord in order to avoid liquid ingress.
Please complete the enclosed response form so we may follow up with any further actions as
necessary.
Details of steps 1, 2, 3
are included in the
Operator’s Manual

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This notice needs to be passed on all those who need to be aware within your organization or to
any organization where the potentially affected devices have been transferred.
If you have any questions, please contact Edwards Customer Service or Tech Support at
<phone>
Sincerely,
Vice President of Quality, Critical Care
This Urgent Field Safety Notice has been communicated by Edwards Lifesciences to the relevant
competent authority.

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URGENT FIELD SAFETY NOTICE –
FCA #128
EV1000
Model Numbers: EV1000A, EV1000NI
Lot Numbers: All lots for models listed
CUSTOMER ACKNOWLEDGEMENT
<Customer #>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Please follow all instructions below to complete the acknowledgement process.
Complete this acknowledgement form with the following information:
 DO NOT return any product
 Verify your inventory and correct setup of the system
 Complete all sections of the table below, indicate “0” if you have no product
 Fax/e-mail the completed form to Edwards Customer Service or Tech Support at
<phone>, within 10 days from receipt of this notification
 A follow-up communication will be sent with further instructions.
Model
Serial
Number Ship To Date
Quantity
Shipped
From EW
Number of
Units on hand
Name (Print):
Title/Dept.
Telephone Number:
Signature:
Date:
Please return this form via fax to Edwards Customer Service or Tech Support at: <phone>

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URGENT FIELD SAFETY NOTICE
ADDENDUM
FCA #128
EV1000
Model Numbers: EV1000A, EV1000NI
Lot Numbers: All lots for models listed
<MM DD, YYYY>
<Customer #>
<Contact name or Dept.>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Dear Valued Customer:
This letter is in follow-up to our initial communication regarding EV1000 monitors and the risk
associated with smoke, sparks or fire related to the power supply.
In our initial communication, we noted that improper mounting of the power supply could result in
liquid ingress into the adaptor causing a short with the potential to lead to a possible fire hazard.
This letter is to inform you of additional potential causes, our plans to address the issues, and
steps you can take to help minimize risk.
Reports of Burnt Cables:
•We have reports of cables that appear burnt, without smoke, sparks or fire. We continue to
investigate to identify all potential causes. One potential cause is the presence of conductive
material in the AC inlet of the power supply.
•Please assure that there is no conductive material in or near the AC inlet when connecting the
AC power cord to the EV1000 power supply, and that both the AC power cord and inlet are
clean and dry.
Reports of Smoke, Sparks or Fire due to Cleaning or Decontamination/Disinfection:
•The product instructions indicate that product should be kept dry and the cables should not be
immersed in any liquid solution or liquids allowed to penetrate connectors.

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•Another opportunity for liquid ingress into the power supply could be the cleaning and
disinfection process. Although the cleaning instructions in the EV1000 Operators Manual
indicate both to only wipe with a damp cloth and to dry the cable after cleaning, user reports
indicate that this process is not always followed.
•Please assure that the cleaning instructions as noted in the EV1000 Operators Manual are
followed, and that the AC power cord and inlet are clean and dry prior to use.
Edwards is working to address all of the root causes, and to implement actions on units already in
the field as quickly as possible.
These actions include:
Updated customer notification of all potential causes and mitigations, including ensuring the
AC power cord and inlet are kept clean, dry and free of contamination by conductive materials
prior to use. (completed with this notification).
Updating the Operators Manual to include the instructions as noted above and any others
identified as our investigation continues (in progress).
Visiting your facility to (1) apply a label to the AC power cord to help assure proper orientation
to avoid liquid ingress, and (2) confirm that the area is clear of potential contaminants.
Implementation of design changes that would eliminate or reduce the potential for liquid ingress
and other potential contaminants (identification in progress).
This notice needs to be passed on all those who need to be aware within your organization or to
any organization where the potentially affected devices have been transferred.
If you have any questions, please contact Edwards Customer Service or Tech Support at
<phone>
Sincerely,
Vice President of Quality, Critical Care
This Urgent Field Safety Notice has been communicated by Edwards Lifesciences to the relevant
competent authority.

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URGENT FIELD SAFETY NOTICE
ADDENDUM
FCA #128
EV1000
Model Numbers: EV1000A, EV1000NI
Lot Numbers: All lots for models listed
CUSTOMER ACKNOWLEDGEMENT
<Contact name or Dept.>
<Firm Name>
<Attention: RISK MANAGEMENT>
<Address>
<City/state/zip>
Please follow all instructions below to complete the acknowledgement process.
Complete this acknowledgement form to confirm that you received this addendum:
•DO NOT return any product
•Email the completed form to Edwards Tech Support at [e-mail],
within 10 days from receipt of this notification
Name (Print):
Title/Dept.:
Firm Name:
Telephone Number:
Signature:
Date:
Please return this form via email to Edwards Tech Support at [e-mail]
Support at: <phone>