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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 09/24/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was returned to baxter healthcare for evaluation.A review of service history revealed previous device servicing did not cause or contribute to the reported difficulty.A review of the device logs did not verify the reported issue of a returned instrument testing evaluation (rite) functional test failure during the volumetric accuracy test.An internal and external inspection was performed on the device and the device passed.The device passed rite electrical testing.A manual volumetric accuracy test was performed and the device failed.The door piston foam was replaced with a test article and the manual volumetric accuracy test passed specifications.The original door piston foam was found to be too deteriorated to place back into the device.A manual temperature test was completed and passed specifications.A check of the door assembly found the door piston cracked at the side of the left disposable.The cause for the rite functional test failure for volumetric accuracy was determined to be caused by deteriorated door piston foam and cracked door piston.The piston and foam were replaced to resolve the problem.This issue is being investigated through a capa.Should additional relevant information become available, a supplemental report will be submitted.
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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 fluid volume accuracy testing.Device failed during evaluation, no patient involved.
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Manufacturer Narrative
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(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a follow-up report will be submitted.
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Search Alerts/Recalls
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