Catalog Number 688410/B |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2018 |
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 a hemodynamic monitoring procedure the pm set was found to be leaking at a septum connection.The defective device was discarded by the account.No patient injury to report.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.Only eight unused units from the same lot were returned.The devices were examined visually and functional testing was performed.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 complaint for this lot number was found.Corrective actions are in process.
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Search Alerts/Recalls
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