Catalog Number C1303670 |
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 12/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has 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 while prepping a pressure transducer set for the hemodynamic monitoring of a patient, the set was found to be leaking at the planecta.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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