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Service Bulletin
Product Code(s) Affected: 1M8550/1M8550R
Product Name: Auto Syringe AS50 Infusion Pump
Usage: (X) Internal / (X) External
Title: Auto Syringe AS50 Infusion Pump Rear Case Inspection and Replacement
1.0 PURPOSE
Provide instructions for inspection of AS50 Rear Case Assemblies installed in AS50 Volumetric
Infusion Pumps and part numbers AAS5001531RP, AAS5001530RPand A069160000RP for presence
of incorrectly assembled ESD Squares.
2.0 APPLICABILITY
Baxter Service Centers
These service instructions are applicable to Baxter Service Centers, and Field Service Engineers
providing service for the Auto Syringe AS50 Infusion Pumps.
Baxter trained Self-Servicing customers
These service instructions are provided to detail the process to inspect the Rear Case Assembly ESD
squares of the AS50 Infusion Pump.
Implementation of these instructions is an optional alternative to sending the pump to the Baxter Service
Center for inspection.
Opting to perform this service bulletin acknowledges agreement to remove all Auto Syringe AS50
Volumetric Infusion Pumps with incorrectly assembled ESD Squares and return the Customer
Inspection Documentation to Baxter within 30 days of receipt of this service bulletin; and replacement
of affected rear case assemblies within 6 months.
2.1 Applicable Documents
AS3AB3001 Auto Syringe AS50 Infusion Pump Service Manual
3.0 BACKGROUND
Baxter, and AS50 are registered trademarks of Baxter International Inc.
© Copyright 2008, Baxter Healthcare Corporation. All Rights Reserved
Document Number: 07-27-58-711
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On September 5, 2008 Baxter Healthcare Corporation communicated an Urgent Product Recall,
2008-043 MD, concerning the AS50 Infusion Pump product codes 1M8550 and 1M8550R serviced or
repaired with part numbers AAS5001530RP, AAS5001531RP, or A069160000RP from November 1,
2007 to July 29, 2008.
The Rear Case assemblies were manufactured with ESD grounding squares that may have been
manufactured with the adhesive applied to the incorrect side resulting in exposure of the conductive
surface of the I/O board. Pumps that have been serviced or repaired with these components could short
circuit resulting in a loss of audio and/or interruption of therapy.
4.0 GENERAL INFORMATION
4.1 Materials Required
Replacement Rear Case Assembly Part Numbers AAS5001531RP, or AAS5001530RP, or
A069160000RP
4.2 Warnings and Cautions
! WARNING ! Repairs, upgrades and inspections shall be performed by qualified Baxter employees
or Baxter-trained qualified personnel, using only Baxter specified parts, and servicing
instructions or manuals that are provided by Baxter.
CAUTION! The pump contains ESD susceptible components. Establish appropriate ESD controlled
workspace prior to conducting this procedure. This includes use of a properly grounded
anti-static mat and a grounded wrist strap.
5.0 PROCEDURE
5.1 Remove the rear case assembly per the instruction in the Auto Syringe AS50 Infusion Pump Service
Manual
5.2 Remove the I/O board per the instructions in the Auto Syringe AS50 Infusion Pump Service Manual
5.3 Inspect the ESD Grounding Squares shown in the illustrations below.
Critical Note: Baxter trained Self-Servicing customers only
If the grounding squares are non-conforming, remove the pump from service, complete the Customer
Inspection Documentation Form, and return the form to Baxter within 30 days of receipt of this service
bulletin.
5.4 Upon receipt of replacement rear case assemblies from Baxter, verify the replacement rear case
assembly grounding squares are correctly assembled per the illustrations below.
5.5 Follow the instructions in the service manual to replace the non-conforming rear case assemblies.
5.6 Mark “6” on the device configuration label, located inside the battery cover.
5.7 Perform required Calibration, Functional and Final Testing prior to placing device back into
service.
Baxter, and AS50 are registered trademarks of Baxter International Inc.
© Copyright 2008, Baxter Healthcare Corporation. All Rights Reserved
Document Number: 07-27-58-711
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N
on-conforming
ESD Squares are
evident by Copper
Foil face up.
Baxter, and AS50 are registered trademarks of Baxter International Inc.
© Copyright 2008, Baxter Healthcare Corporation. All Rights Reserved
Document Number: 07-27-58-711
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6.0 DOCUMENTATION
Baxter Service Centers
Complete documentation of Calibration and Functional testing as defined by internal Service
Procedures:
AS5AB1004 AS50 Calibration Procedure
AS5AB1009 AS50 Functional Test Procedure
Completion of service activity defined by this Service Bulletin will be documented on the Service
Order.
Baxter trained Self-Servicing customers
Complete documentation of Calibration and Functional testing as indicated by AS3AB3001Auto
Syringe AS50 Infusion Pump Service Manual or per facility operating procedure.
Complete the Customer Inspection Documentation Form and Fax to 1 (847) 270 5457 within 30 days of
receipt of this service bulletin. Receipt of this documentation by Baxter will prevent repeat requests for
information.
Baxter, and AS50 are registered trademarks of Baxter International Inc.
© Copyright 2008, Baxter Healthcare Corporation. All Rights Reserved
Document Number: 07-27-58-711
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Customer Inspection Documentation Form
AS50 Infusion Pump, Product Codes 1M8550 and 1M8550R
AS50 Infusion Pump Rear Case Assembly Product Codes AAS5001530RP/
AAS5001531RP/A069160000RP
URGENT PRODUCT RECALL - CUSTOMER SERVICE REPLY FORM
Please complete and return this form to the FAX number listed below as confirmation that you
have received this notification. Please check all that apply. A fax cover sheet is not required.
Facility Name and Address:
We have examined our inventory and completed inspection of AS50 pumps. The AS50 pumps as listed in
this notification have been removed from service until such time that remediation is complete. Please use
multiple reply forms if necessary.
Serial Number Serial Number Serial Number Serial Number
We understand the contents of the Service Bulletin and performed the actions as outlined.
Required Fields:
Reply Completed By:
(Signature/Date)
Name:
(Please Print Name)
Title:
(Please Print)
Telephone Number:
(Including Area Code)
Baxter, and AS50 are registered trademarks of Baxter International Inc.
© Copyright 2008, Baxter Healthcare Corporation. All Rights Reserved
Document Number: 07-27-58-711
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