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Baxter Peritoneal dialysis machines
<Adelaide tech>
Do anybody now how often the Baxter peritoneal dialysis machines need to be serviced.
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Date: June 25, 2009
Subject: HomeChoice and HomeChoice Pro
Product Code 5C4471 and 5C8310
This letter addresses HomeChoice
verification and details the instrument reconditioning process
Baxter Healthcare Corporation
regulations per 21 CFR, part 820, Good Manufacturing Practices.
All Baxter medical device manufacturing facilities are registered with the FDA.
As such, all instrumentation shipped must meet product specifications. This includes
both new and reconditioned HomeChoice
Baxter performs final testing and inspection on all medical devices manufactured (new
and reconditioned) prior to their release for shipment. Every
HomeChoice Pro system released from the Baxter manufacturing facility has
undergone the following:
· Sanitization
· Evaluation of device
· Replacement/repair/upgrade of device components, as appl
· Electrical safety testing
· Software verification
· Subassembly functionality testing, including those for pumps, door and cover
· Final inspection
· Final testing and calibration, which includes testing for
fluid accountability, and
The HomeChoice and HomeChoice Pro
maintenance or performance verification by the user or renal care facility.
up, the HomeChoice system performs an exte
electrical and/or mechanical failures. Calibration is checked and performance
parameters are verified during the self
the system will not proceed into operation.
Baxter Healthcare Corporation
1620 Waukegan Road
McGaw Park, IL 60085
Phone: 847.473.6303
Fax: 847.473.6888
Automated Peritoneal Dialysis Systems
and HomeChoice Pro APD system performance
builds all U.S. medical instrumentation to meet FDA
and HomeChoice Pro APD systems.
) HomeChoice
pumping accuracy
, any other functional performance tests necessary
APD systems require no routine preventive
extensive self-check procedure to detect any
self-check. If the self-check parameters are not met,
umping and
Upon power
In the event that a leased HomeChoice system has an operational problem requiring
replacement, Baxter will arrange to have the system picked up and a replacement
system delivered to the patient the day after Baxter receives notification. The
replacement system may be reconditioned or new. Regardless of whether the
HomeChoice system is new or reconditioned, the instrument will meet Baxter’s original
manufacturer’s operational specifications for effectiveness and reliability. As such, any
HomeChoice system that has been reconditioned by Baxter functions under the
same operating conditions as a brand new machine, and is therefore considered
equivalent to a new machine.
For any further information about servicing HomeChoice APD systems, please contact
Baxter Global Technical Services by calling 1-800-553-6898.
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