BD ALARIS 8015 Service Bulletin

BD
Brand
BD
Model
ALARIS 8015
Type
Service Bulletin

This manual is also suitable for

BD ALARIS 8015

The BD ALARIS 8015 is a versatile and user-friendly medical device that offers a wide range of features and capabilities to meet the diverse needs of healthcare professionals.

BD ALARIS 8015

The BD ALARIS 8015 is a versatile and user-friendly medical device that offers a wide range of features and capabilities to meet the diverse needs of healthcare professionals.

Service Bulletin 621
PN P00000360 DIR No.: 10000351665 Version: 00 Page 1 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0204-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
Products Affected: Alaris™ Pump Module
BD Alaris™ System Maintenance
Alaris™ System Maintenance
Date: April 2019
Subject: Inspecting the Alaris™ Pump Module Bezel
Purpose
This bulletin provides the following information:
• How to identify Alaris™ pump modules that are affected by the bezel assembly recall
• How to identify pump modules that are not affected by the bezel assembly recall
• How to perform the bezel inspection during the routine preventive maintenance
schedule
References
• Alaris
®
PC Unit, Models 8000 and 8015 Alaris
®
Pump Module, Model 8100 Technical
Service Manual (P/N 12239273, ordered as P/N 10848481)
• Alaris™ PC Unit, Model 8015 and Alaris Pump Module, Model 8100 Technical Service
Manual (P/N P00000171, ordered as P/N 49000395)
• BD Alaris™ PC Unit, Model 8015 and BD Alaris™ Pump Module, Model 8100 Technical
Service Manual (P/N P00000232 ordered as P/N 49000430)
• BD Alaris™ System Maintenance Model 8975, v12.1.0 Software User Manual
(P/N P00000326)
• BD Alaris™ System Maintenance Model 8975, v12.0.1 Software User Manual
(P/N P00000289)
• Alaris™ System Maintenance Model 8975 v10.33 Software User Manual
(P/N P00000285)
• Alaris™ System Maintenance v10.19 Software User Manual
(P/N P00000320)
PN P00000360 DIR No.: 10000351665 Version: 00 Page 2 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
Accessing Documentation
For North American customers, service manuals, service bulletins, and software upgrade
instructions are available through the Customer Portal. The link below takes you to the
portal’s Welcome screen:
https://cp.carefusion.com/
1. If you are registered, enter your email and password, and click
LOGIN. If you are not
registered yet, click
SIGN UP, and follow the prompts.
2. On the Customer Portal home page, click
CONTENT LIBRARY.
3. When the library page appears, select
Service bulletins and manuals in the Content
Type field to find the information you seek.
For customers outside of North America, contact CareFusion Customer Support with
Infusion Technical queries/questions at: GMB-INTL-T[email protected].
Parts and Tools Required
• #1 Phillips screwdriver (refer to the technical service manual for proper torque values)
• #2 Phillips screwdriver (refer to the technical service manual for proper torque values)
• Needle-nose pliers
• Small diagonal cutters
• Pick tool
• Flashlight with magnifier
Inspecting the Alaris™ Pump Module Bezel
PN P00000360 DIR No.: 10000351665 Version: 00 Page 3 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Explanation
BD has initiated a recall expansion of the Alaris pump module to include all bezels
manufactured between April 2011 and June 2017. All of the bezels subject to this recall
expansion were manufactured with a specific type of plastic, called FR-110. BD’s ongoing
investigation has determined that the bezel manufacturing process for the FR-110 plastic
may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to
separation of the bezel post (recall issue) as well as other damage to the bezel (for
example, external cracking). The separation of one or more bezel posts is a potential safety
concern. Affected pumps have different levels of potential risk.
Until the bezels affected by this recall are replaced by BD or deemed unaffected in
accordance with this inspection procedure, customers should inspect bezels during their
annual preventive maintenance schedule. Any pumps with separated bezel posts should be
removed from service.
This service bulletin provides the instructions and pictures to assist with the bezel
inspection during the annual preventive maintenance schedule. After performing the
identification procedures below, any pump modules that are identified as unaffected by the
bezel recall do not require reinspection during their routine preventive maintenance.
NOTE:
The following pump modules are not affected by the bezel recall:
• BD Alaris™ pump modules
• Alaris pump modules manufactured after June 2017
• Alaris pump modules serviced with bezel assembly kit P/N 49000270
• Alaris pump modules that were manufactured prior to April 2011 and have not been serviced with
customer-ordered bezel assembly kits P/N 10964559 or P/N 49000204
PN P00000360 DIR No.: 10000351665 Version: 00 Page 4 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
Identifying Alaris™ Pump Modules Not Affected by the Recall
1. If the pump module uses BD branding (BD Alaris™ pump module), it is not affected by
this recall.
BD branding
Inspecting the Alaris™ Pump Module Bezel
PN P00000360 DIR No.: 10000351665 Version: 00 Page 5 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
2. There are two variations of the bezel that can be differentiated by the lower door hinge:
one variation has a notch on the lower door hinge and the other does not. To identify
which bezel your pump module has:
a. Open the pump module door and hold down the platen to view the lower door hinge.
If the lower door hinge has a notch, the recall does not affect this pump module.
Mark the pump module as unaffected by the recall. If the lower door hinge does not
have a notch, proceed to Inspecting the Bezel for External Damage on page 6.
NOTE:
Alaris pump modules, manufactured prior to April 2011, do not have a notch in the lower door hinge.
If these pump modules are encountered and have not been serviced with customer-ordered bezel
assembly kits P/N 10964559 or P/N 49000204, the recall does not affect these pump modules.
No notch
(recalled)
Notch
(not recalled)
Platen
PN P00000360 DIR No.: 10000351665 Version: 00 Page 6 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
Inspecting the Bezel for External Damage
1. Inspect the bezel hinge for damage. If there is bezel hinge damage, the bezel assembly
must be replaced. Otherwise, continue to Step 2 on page 7.
Examples of bezel hinge damage are shown in the figures below.
Damage
Damage
Inspecting the Alaris™ Pump Module Bezel
PN P00000360 DIR No.: 10000351665 Version: 00 Page 7 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
2. Inspect the bottom of the bezel near the air-in-line mechanism for damage. If there is
bezel damage, the bezel assembly must be replaced. Otherwise, continue to Step 3 on
page 8.
Example of bezel damage near the air-in-line mechanism shown in the figure below.
Damage
Damage
PN P00000360 DIR No.: 10000351665 Version: 00 Page 8 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
3. Remove the platen assembly and membrane frame assembly. Refer to the technical
service manual for disassembly instructions.
4. Inspect the bezel behind the membrane frame assembly for damage. If there is bezel
damage, the bezel assembly must be replaced. Otherwise, continue to Inspecting the
Bezel for Internal Damage on page 9.
Example of bezel damage behind the membrane frame shown in the figure below.
Damage
Inspecting the Alaris™ Pump Module Bezel
PN P00000360 DIR No.: 10000351665 Version: 00 Page 9 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Bezel for Internal Damage
1. Close the pump module door and remove the rear case from the chassis assembly.
Refer to the technical service manual for disassembly instructions.
2. Inspect the bezel for damage. If there is bezel damage, the bezel assembly must be
replaced. Otherwise, continue to Inspecting the Bezel Posts on page 10.
Examples of bezel damage are shown in the figures below.
Damage
Damage
PN P00000360 DIR No.: 10000351665 Version: 00 Page 10 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
Inspecting the Bezel Posts
1. Disconnect the display board harness (J2).
2. Using the diagonal cutters, lift and remove the snap rivet from the logic board. Be
careful not to cut the snap rivet while removing it.
3. Remove the two screws from the logic board.
Damage
Damage
Inspecting the Alaris™ Pump Module Bezel
PN P00000360 DIR No.: 10000351665 Version: 00 Page 11 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
4. Lift the logic board and inspect for damaged or separated bezel posts.
If there are any damaged or separated bezel posts, the bezel must be replaced. If there
are no damaged or separated bezel posts, continue to Step 5.
[
Bezel posts
Damaged
bezel post
Separated
bezel posts
PN P00000360 DIR No.: 10000351665 Version: 00 Page 12 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
5. Reinstall the logic board. Refer to the technical service manual for reassembly
instructions.
6. Lifting the motor control board:
a. Remove the motor control board screw.
b. Using the diagonal cutters, lift and remove the snap rivet from the motor control
board. Be careful not to cut the snap rivet while removing it.
7. Lift the motor control board and inspect for damaged or separated bezel posts.
If there are damaged or separated bezel posts, the bezel must be replaced. If there are
no damaged or separated bezel posts, continue to Step 8.
8. Reinstall the motor control board. Refer to the technical service manual for reassembly
instructions. Continue to Reassembling and Testing the Alaris™ Pump Module on
page 13.
Bezel posts
Inspecting the Alaris™ Pump Module Bezel
PN P00000360 DIR No.: 10000351665 Version: 00 Page 13 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Reassembling and Testing the Alaris™ Pump Module
1. Reinstall the rear case. Refer to the technical service manual for reassembly
instructions.
2. Reinstall the membrane assembly and platen assembly. Refer to the technical service
manual for reassembly instructions.
3. Perform preventive maintenance according to the system maintenance software user
manual.
4. Pump modules that successfully pass the preventive maintenance tests can be returned
to service. Until the bezels affected by this recall are replaced by BD or deemed
unaffected in accordance with this inspection procedure, customers should reinspect
bezels during their annual preventive maintenance schedule. Any pump modules with
separated bezel posts should be removed from service.
PN P00000360 DIR No.: 10000351665 Version: 00 Page 14 of 14
Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17
DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approvers
DOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16
Inspecting the Alaris™ Pump Module Bezel
CareFusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego, CA 92121
United States
888.876.4287
858.617.2000
Authorized EU Representative
BD Switzerland Sàrl
Route de Crassier 17
Business Park Terre-Bonne
Batiment A4
1262 Eysins
Switzerland
Technical Inquiries:
Contact information is available on the CareFusion
website:
http://www.bd.com/en-us/support
© 2019 CareFusion Corporation or one of its affiliates.
All rights reserved.
BD and the BD Logo are trademarks of Becton,
Dickinson and Company.
CareFusion, Alaris, and Guardrails are registered
trademarks of CareFusion Corporation or one of its
affiliates.
All other trademarks are the property of their
respective owners.
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BD ALARIS 8015 Service Bulletin

BD
Brand
BD
Model
ALARIS 8015
Type
Service Bulletin
This manual is also suitable for

BD ALARIS 8015

The BD ALARIS 8015 is a versatile and user-friendly medical device that offers a wide range of features and capabilities to meet the diverse needs of healthcare professionals.

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