Field Safety Corrective Action

To : Whom it may concern Telephone : :local affiliate

From : [local affiliate] Telefax : :local affiliate

Date : 30-Jun-2014

Subject : AMIKA Wall Plug

This Field Safety Corrective Action affects the following products:

Product name Article number

Amika CO Z044141
Amika DE Z044120
Amika FI Z044151
Amika FR Z044110
Amika GB Z044130
Amika INT Z044190
Amika IT Z044160
Amika NL Z044170
Amika NO Z044155
Amika PL Z044193
Amika RO Z044148
Amika SE Z044150
Amika ZA Z044191

Dear Customer / Health Professional,

Fresenius Kabi has identified a potential risk with the wall plug of the AMIKA nutrition pump.

In some cases, when the Wall plug falls to the ground, when handling the Wall plug, or when
disconnecting it from the mains, the housing can break, thus potentially leaving the electronics
as partly unprotected.
If the problem appears when Wall plug is connected to the mains, there is a risk of electric
shock or electrocution for the user, in case he/she accidentally touches the small live parts
inside.

Page 1 of 4
Up until the creation of this FSCA, Fresenius Kabi has not received any reports regarding
injuries from the field.

To identify if the Wall plug is affected by this FSCA please check the Serial Number
which you can find on the wall facing side.

REFERENCE &
SERIAL
NUMBER
LOCATION

All Serial Numbers below 00019160 are affected. All of these parts will be replaced
by Fresenius Kabi.

Fresenius Kabi recommends that users take the following precautions and action:

Until the replacement of Wall Plug, Fresenius Kabi recommends the following:

1. Unplug the Wall Plug from the mains. If the front and rear housing separation starts
when unplugging the device, ensure to handle and touch only plastic housing, until the
device is fully disconnected

2. Verify that the front and rear housing are well attached together.

3. If there is a gap between the front and rear housing, a gap appears when trying to
separate the front and rear housing
or if the front and rear housing are not attached anymore;
stop using the Wall plug immediately, and ensure no-one will use it.

Page 2 of 4
PLEASE COMPLETE THE ENCLOSED “URGENT PRODUCT FSCA RESPONSE FORM” AND SEND IT
BACK TO US IMMEDIATELY AT:
E-mail: <local affiliate>
Fax: <local affiliate>

Fresenius Kabi will than organize the replacement.

Please assure within your organization that every user of the concerned products and all other
relevant persons are informed about this letter and the risks as described herein.

Fresenius Kabi is committed to providing you with the highest level of service, product quality
and reliability. We apologize for any inconvenience.

If you have any further questions concerning the FSCA please contact: local product manager.

Sincerely,

Signature

<name local affiliate>

<function>

Page 3 of 4
 URGENT PRODUCT FSCA RESPONSE FORM
AMIKA Wall plug

SECTION A
Hospital / Facility Details
Please fill out the information below and send the completed form to Fresenius Kabi at:
E-mail: <local affiliate> or Fax: <local affiliate>

Name of Hospital /
Facility:

Hospital / Facility
Address:

Telephone Number:

Signature:

Date:

SECTION B

I have read and have understood the l instructions provided in the [date] letter.

I have checked my inventory and this is consisting of _____ <units >, which have to be
replaced.

Page 4 of 4