Catalog Number 688650 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Event Description
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The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring set was found to be leaking fluid at the connections before use.The pm set was exchanged for a new set and the monitoring successfully completed.No patient injury to report.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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