Model Number 10-80-00 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device but he could not reproduce the reported issue.He replaced the bubble sensor and the associated module as precaution.He tested the unit intensively without any failures.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova (b)(4) received a report of a s5 roller pump malfunction during ecmo.The bubble sensor turned red and stopped the pump.It was not showing any error message and there was no audible alarm.Before the specialist could respond by clamping the arterial line disconnecting the patient from ecmo, the pump re-started without anyone acknowledging the bubble alarm.It is unknown whether air went to the patient.
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Event Description
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See initial report.
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Manufacturer Narrative
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H.10: the replaced units have been requested by livanova for investigation.No deviations have been detected with the bubble sensor and the bubble sensor module.Based on the above facts, it is possible to exclude a pump malfunction.Most likely an incorrect alarm management may have led to the reported event.
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Search Alerts/Recalls
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