Catalog Number INS1100 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Type
Injury
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Manufacturer Narrative
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The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 2648988-2018-00043, 2648988-2018-00045 and 2648988-2018-00046.
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Event Description
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This is 2 of 4 reports.The account manager reported on behalf of the customer that the failures of breakage or leakage of fluid due to a crack occurred while using the ins1100 (csf drainage system used with pole mount system).All the breaks happened in the exact same location, at the stopcock where the fluid-coupled transducer was attached.Different patients were involved.No additional patient or product details were recorded or saved.The drains were discarded.
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Manufacturer Narrative
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The device was not returned for evaluation.The device history record cannot be performed as there was no lot number provided.The reported condition could not be confirmed, and no further analysis is possible.The root cause is undetermined.(b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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