Model Number HEM1 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned as the serial number of the device is unknown, the exact device involved cannot be determined.As the serial number is unknown, the udi information is unknown.The device history record review cannot be completed as the serial number is unknown.The diagnostic logs have been requested.A supplemental report will be submitted if there is any information from the logs that is able to be provided.
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Event Description
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It was reported that there were inaccurate low ci values of 1.5 with the hemosphere instrument, hem1.The patient was a non-cardiac surgical patient with no cardiac history.A female patient and the procedure was a colostomy takedown.There are no other hemodynamic values that are available.The patient was not treated for the low ci values.This was during patient use.There was no patient injury.
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Manufacturer Narrative
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The diagnostic logs were returned for review.The data analyzed shows no indication of inaccurate co ci measurements.The issue appears to be the clinician's inexperience with the hsni system.The hsni and ev1000 systems use slightly different co algorithms.The data determined that the patient exhibited symptoms of a hypovolemic condition in which the co and ci must be low.Low ci was confirmed through the clinical data analysis.The raw arterial pressure waveforms from the patient was reprocessed through the algorithm for the ev1000 monitor.The resulting co ci data was compared to the co ci data from the hem1 monitor.Both data sets showed similar low ci measurements, well below 2.0 l min m2.The data from the hem1 device is consistent with the ev1000 device.The assignable cause of the issue is design.The issue could not be confirmed.There was no defect identified during the investigation.A risk assessment and corrective action were initiated for this issue.H3 other text : diagnostic log review.
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Manufacturer Narrative
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Correction update, after additional review, the data logs appeared to correlate to the reported event description; however, the edwards rep could not confirm the date.Additionally, the edwards rep did recall that the issue occurred on either 6/30/2021 or 7/1/2021, which is a correction from the originally reported date of 06/29/2021.H3 other text : log files reviewed.
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Search Alerts/Recalls
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