Baxter AS50 User manual

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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