Model Number SCCS1002 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that as per the investigation, users expressed inaccurate hourly urine output (did not capture less than 40cc) for this sensica device.
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Manufacturer Narrative
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The reported issue was confirmed design related.The identified root causes is ¿software issues¿ as it was confirmed that due to certain software steps being interrupted, that uo was not being reported or calculated correctly.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because labeling could not have prevented this issue.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Event Description
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It was reported that as per the investigation, users expressed inaccurate hourly urine output (did not capture less than 40cc) for this sensica device.
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Search Alerts/Recalls
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