Catalog Number 5C5479 |
Device Problem
Malposition of Device (2616)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Event Description
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It was reported that an amia automated pd set with cassette had a borla clamp that was slightly misaligned while clamped, resulting in incomplete occlusion of the solution line and leakage from the solution line.This was noticed during testing by the reporting facility and prior to patient use.There was no patient involvement.No additional information is available.This is report 1 of 2.
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Manufacturer Narrative
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(b)(4).The device is reported to be available for evaluation.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).A review of all batch record documents was performed for potentially associated lot number h13k13030 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).A device was returned to baxter for evaluation.The sample was visually inspected with no issues noted.Functional testing included leak, clamp function, and clear passage testing was completed with no issues noted.The sample analysis did not verify the reported problem.Should additional relevant information become available, a supplemental report will be filed.
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Search Alerts/Recalls
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