Service Information D 1720 (EN) 2010-09-06
Fresenius Medical Care
Hemodialysis systems (5008, 5008S, 4008)
Loose protective caps on the microswitch of the bibag
connector and the shunt interlock
Summary:
Systems affected All 5008 / 5008S dialysis systems as well as all 4008 devices
equipped with 5008-type bibag connectors.
Measure The protective caps on the microswitch of the bibag connector
and the shunt interlock became loose because of an insufficient
contact force.
An adjusting washer was introduced as an interim solution to
increase the contact force.
The adjusting washer can now be omitted as the support
bushing (see fig. on the following pages) was modified.
Priority None
Compatibility The modified support bushing is fully compatible. It must,
however, be ensured that it is not installed together with the
adjusting washer.
Logistics See following pages
Documentation Supplement to existing technical documentation.
Modifications to the system have to be documented in the
Medical Device Register and the service report.
Introduction in series The new support bushing is introduced in series production with
production the following equipment code:
5008 Hydraulics EC119, System EC905
5008S Hydraulics EC059, System EC585
Relevant for operation Not affected
Enclosures:
None
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Page 1 of 4
Service Information D 1720 (EN) 2010-09-06
Å Page 1
Fresenius Medical Care
Hemodialysis systems (5008, 5008S, 4008)
Systems affected
All 5008 / 5008S dialysis systems as well as all 4008 devices equipped with 5008-type
bibag connectors.
Measure
An adjusting washer was used as interim solution as the protective caps on the
microswitch of the bibag connector and the shunt interlock became loose.
This washer was necessary to increase the contact force on the protective cap and thus
to prevent the latter from becoming loose.
Fig.: Example bibag connector Fig.: Previous composition with adjusting
washer
Protective cap
Support bushing
Adjusting washer
To facilitate the assembly, the thickness of the support bushing was changed (see fig.
below), which in turn allows omitting the adjusting washer.
Fig.: Modified support bushing (left), previous support bushing (right)
Edge thickness 0.5 mm
Edge thickness 0.9 mm
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Service Information D 1720 (EN) 2010-09-06
Å Page 1
Fresenius Medical Care
Hemodialysis systems (5008, 5008S, 4008)
Note
The modified support bushing will from now on be installed on the shunt
interlock and the bibag connector in the systems supplied in series.
The modified support bushing must not be installed together with the adjusting
washer.
Priority
None
Compatibility
The modified support bushing is fully compatible. It must, however, be ensured that it is
not installed together with the adjusting washer.
Logistics
Description Part number
Sensors, Shunt Interlock M36 901 1
Sensor, Bag Connected (bibag) M33 481 1
Cap For Micro Switch M32 979 1
Adjusting washer 673 654 1
(The adjusting washer will still be available for systems with an equipment
code lower than described above.)
The modified support bushing is not available as separate spare part but it is comprised
in the sensor spare parts.
Documentation
The contents of this Service Information are a supplement to the existing technical
documentation. Modifications to the system have to be documented in the Medical
Device Register and the service report.
Page 3 of 4
Service Information D 1720 (EN) 2010-09-06
Å Page 1
Fresenius Medical Care
Hemodialysis systems (5008, 5008S, 4008)
Introduction in series production
The new support bushing is introduced in series production with the following equipment
code:
5008 Hydraulics EC119, System EC905
5008S Hydraulics EC059, System EC585
Relevant for operation
Not affected
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