(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.An internal and external inspection was performed and the device passed, along with all of the electrical testing.The fluid volumetric accuracy test that was performed, had failed with the original piston foam.However, when a test article, piston foam, was installed, the device passed the accuracy confirmation testing.The original piston foam was removed and inspection revealed that the piston foam was deteriorated.The evaluation concluded that the cause of the failed fluid volume accuracy testing was the deteriorated piston foam and a cracked door piston.The piston foam and door piston were replaced to solve the reported problem.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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