Catalog Number 10220 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that during a spectra optia exchange procedure, the operator noticed a misassembly of the roller clamp.The roller clamp from the saline return line was placed on the return line tubing.Patient information and outcome are not available at this time.The spectra optia exchange set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information.
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Event Description
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The customer declined to provide patient information.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the cause of this defect was related to a misassembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.
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Search Alerts/Recalls
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