Quality Management 01 / 2012

Subject: Interim report on stepper motors

Pump model: Volumetric pumps A707/708 V

Date: February 2012

Our analysis:

Based on feedback from individual countries, we have noticed an unusual number of F51 / F52 error
messages.
The motors we have examined display increased clearance in the ball-bearing area. When the affect-
ed motors were opened, a rust-brown liquid or rust-brown dust was visible in the deep-groove ball
bearings. This suggests a high level of friction which, at worst, may lead to the motor locking.

Patient safety is ensured by an alarm being triggered, indicating a technical fault.

The average fault rate of affected motors is calculated as around 0.7 – 1%; however in individual
batches it is significantly higher.

Codan Argus AG’s Quality Assurance department has been working with the manufacturer for
months to identify the causes and the action to be taken.

Measures implemented and future measures:

1. The manufacturer carried out various functional tests during 2011 and thoroughly examined
the product and process specifications.
2. As a result, the assembly procedure for the bearing pressure has been optimised; this should
achieve more uniform results for the ball-bearing tolerances over large batches.
3. To monitor the optimised assembly process, the manufacturer has initiated accelerated long-
term tests, which are being carried out under the operating conditions specified by Codan
Argus.
4. In addition, Codan Argus, together with the manufacturer, is looking at ways of optimising
ball-bearing quality and lubrication.
5. For several months now, Codan Argus has been assessing the products of various other man-
ufacturers in order to set up alternative supply sources.

18.167 CODAN ARGUS AG 06.02.2012 / CK 1/2

Quality Management 01 / 2012

Outlook:

As a result of the optimisation during assembly at the manufacturer’s works, we expect there to be a
significant decrease in the fault rate.
We shall inform you about the long-term tests already underway and their results in three months’
time at the latest.
Further optimisations will in turn have to be confirmed by an accelerated long-term test.

CODAN ARGUS AG

Michael Lüscher Christine Kipfer

Quality Assurance Head of Marketing

18.167 CODAN ARGUS AG 06.02.2012 / CK 2/2