Catalog Number 689401 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 06/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device is 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 blood.The pm set was exchanged for a new set and the monitoring successfully completed with no additional consequences to the patient.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The device was examined visually.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record and complaint database could not be performed since a lot number was not provided.
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Search Alerts/Recalls
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