Model Number 25-40-45 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 gas blender system stopped working properly and the arterial blood started to turn a darker color and the venous saturations began dropping during a procedure.A backup gas blender was used to continue the procedure.There was no report of patient injury.The device has been requested for return to sorin group (b)(4) for investigation.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that the s5 gas blender system stopped working properly and the arterial blood started to turn a darker color and the venous saturations began dropping during a procedure.A backup gas blender was used to continue the procedure.There was no report of patient injury.
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The complained gas blender was returned to sorin group (b)(4) for investigation.Visual inspection did not identify any defects or abnormalities and the issue was not reproduced during functional testing.The device worked within specification.A functional check and new calibration were performed.Functional control and a technical safety inspection were carried out and no further issues were discovered.The device was cleaned and disinfected and returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.
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Search Alerts/Recalls
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