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BD Alaris 8000 Service Bulletin

Inspecting the pump module bezel

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Products Affected:
Date:
Subject:
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
®
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
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
Alaris™ Pump Module
BD Alaris™ System Maintenance
Alaris™ System Maintenance
April 2019
Inspecting the Alaris™ Pump Module Bezel
®
DIR No.: 10000351665 Version: 00
Service Bulletin 621
Pump Module, Model 8100 Technical
Page 1 of 14

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Summary of Contents for BD Alaris 8000

  • Page 1 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) •...
  • Page 2: Accessing Documentation

    Type , contact CareFusion Customer Support with For customers outside of North America 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) •...
  • Page 3 Inspecting the Alaris™ Pump Module Bezel 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.
  • Page 4 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 PN P00000360 DIR No.: 10000351665 Version: 00...
  • Page 5 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.
  • Page 6 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 PN P00000360...
  • Page 7 Inspecting the Alaris™ Pump Module Bezel Damage 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 PN P00000360 DIR No.: 10000351665 Version: 00...
  • Page 8 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.
  • Page 9 Inspecting the Alaris™ Pump Module Bezel 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.
  • Page 10 Inspecting the Alaris™ Pump Module Bezel Damage Damage 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.
  • Page 11 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 Separated...
  • Page 12 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.
  • Page 13 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.
  • Page 14 © 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.

This manual is also suitable for:

Alaris 8015