Catalog Number 688420/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 10/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device has been returned 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 preparation for a hemodynamic monitoring of a patient, the pressure monitoring set disconnected from the rotating adapter.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 has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective actions are in process.
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Search Alerts/Recalls
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