Catalog Number 5C8310R |
Device Problems
Degraded (1153); Volume Accuracy Problem (1675)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/19/2014 |
Event Type
malfunction
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Event Description
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During evaluation of a returned homechoice (hc) device, a baxter technician determined the hc machine failed the volume accuracy test.Device failed during evaluation, no patient involved.
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Manufacturer Narrative
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(b)(4).The homechoice (hc) was returned and is currently in the process of being evaluated.Should additional relevant information become available, a follow-up report will be submitted.
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Manufacturer Narrative
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(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported issue.An internal and external inspection was performed with no abnormalities noted.The device passed the homechoice rite (return instrument test/evaluation) electrical test but failed the homechoice rite functional test for the accuracy confirmation test.The original piston foam was removed and found that the foam was deteriorated and the door piston was cracked.The direct cause of the reported problem was determined to be due to deteriorated piston foam and cracked door piston.The piston foam and door piston were scrapped and the device was sent for servicing.A service history review was conducted and it was determined that the piston was previously replaced and has subsequently failed in this evaluation.A capa has been opened to investigate the reported problem.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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