Catalog Number 682000/CNA |
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 10/02/2021 |
Event Type
malfunction
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Event Description
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The account alleges that during the hemodynamic monitoring of a patient, the dtx pressure monitoring [pm] set was found to be leaking air and blood at the pressure sensor adapter of the device.The pm set was exchanged, and the procedure was successfully completed.No additional patient consequences to report.No additional patient consequences to report.
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Manufacturer Narrative
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The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
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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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