Catalog Number 686304/B |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 05/01/2019 |
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 procedure was successfully completed with no additional consequences to the patient.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.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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