Catalog Number 688396/B |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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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 at the side of the extraction port.The pm set was exchanged for a new set and the monitoring successfully completed with no adverse patient consequences.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.A root cause could not be identified.A review of the device history record was performed, and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.
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Search Alerts/Recalls
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