Model Number 25-40-45 |
Device Problems
Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the oxygenator did not receive significant flow from the s5 gas blender system during a procedure.An alternative gas blender was connected and the oxygenator began receiving the correct flow.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The service representative performed a soak test for 2 hours at various flows and gas mix settings and was unable to reproduce the reported issue.The unit was replaced with a loan unit and was returned to sorin group (b)(4) for investigation.The investigation is still ongoing.A follow-up 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 oxygenator did not receive significant flow from the s5 gas blender system during a procedure.An alternative gas blender was connected and the oxygenator began receiving the correct flow.There was no patient involvement.
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).The complained gas blender was returned to sorin group (b)(4) for investigation.The reported issue was confirmed during functional testing and could be traced to several defective components.The mass-flow meter/controller for air and o2, the eprom and the front panel were replaced and a functional check and new calibration were performed.Functional control and a technical safety inspection were successfully 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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