Service Bulletin 621

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

PurposeThis 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 1 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0204-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16

Inspecting the Alaris™ Pump Module Bezel

Accessing DocumentationFor 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-TechnicalSupportInfusion@bd.com.

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

PN P00000360 DIR No.: 10000351665 Version: 00 Page 2 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16

Inspecting the Alaris™ Pump Module Bezel

ExplanationBD 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 3 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO 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 Recall1. If the pump module uses BD branding (BD Alaris™ pump module), it is not affected by

this recall.

BD branding

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Inspecting the Alaris™ Pump Module Bezel

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

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Inspecting the Alaris™ Pump Module Bezel

Inspecting the Bezel for External Damage1. 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

PN P00000360 DIR No.: 10000351665 Version: 00 Page 6 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16

Inspecting the Alaris™ Pump Module Bezel

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 7 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO 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

PN P00000360 DIR No.: 10000351665 Version: 00 Page 8 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO 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 Internal Damage1. 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 9 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO 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 Posts1. 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

PN P00000360 DIR No.: 10000351665 Version: 00 Page 10 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16

Inspecting the Alaris™ Pump Module Bezel

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

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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

PN P00000360 DIR No.: 10000351665 Version: 00 Page 12 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16

Inspecting the Alaris™ Pump Module Bezel

Reassembling and Testing the Alaris™ Pump Module1. 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 13 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16

Inspecting the Alaris™ Pump Module Bezel

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PN P00000360 DIR No.: 10000351665 Version: 00 Page 14 of 14Record number 1103-001-008-R-SD-INF, DIR 10000307230, Version 01 Release Date: 16AUG17DOCO Use Only (Approver’s List): 0207-001-001-S (Latest Version) to determine authorized approversDOCO Use Only (Record Format Template) 0204-011-005-R, DIR 10000153640, Ver 02, Release Date: 04APR16