Catalog Number 689311 |
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 11/19/2018 |
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 an arterial pressure monitoring procedure, the set was found to be leaking at a connection next to the placenta.The device was replaced.No patient injury to report.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective actions are in process.
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Search Alerts/Recalls
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