Catalog Number 682051/B |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2021 |
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 [pm] set had detached at the distal end just above the blood collection site.An alarm was triggered to alert the medical staff.The pm set was exchanged, and the procedure was successfully completed.The suspect device was discarded.No patient injury to report.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.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.
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Search Alerts/Recalls
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