Model Number 10884450544157 |
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 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device was not returned for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
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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 was found to be leaking blood from the device tip.The pm set was exchanged, and the procedure was successfully completed.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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