Model Number 10-85-00 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2023 |
Event Type
malfunction
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Event Description
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Livanova deutschland has received a report that the dopple roller pump displayed motor control fail pump error during a procedure.There is no report of any patient injury.
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Manufacturer Narrative
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A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 dopple roller pump.The incident occurred in united states.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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See initial report.
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Manufacturer Narrative
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H10: the affected part was returned to livanova deutschland for a detailed investigation.The following parts need to be replaced: - pump head complete - motor power amplifier (hmf) board - motor control (hms) board - locking ring - s5 case for double roller pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Manufacturer Narrative
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The seal around the base of the head cannot be ordered.Unit need to be sent to the manufacturer for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This report was due on november 22, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted following restoration of the livanova systems.
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Event Description
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See initial report.
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Event Description
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See initial report.
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Manufacturer Narrative
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H10: in order to solve the issue the following parts were actually replaced: - pump head complete; - motor power amplifier (hmf) board; - motor control (hms) board; - locking ring; - s5 case for double roller pump.In addition the nvmem was cleared.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A device service history review has been performed and identified that the unit was manufactured in 2016 and no other similar events have been reported.Based on the available information and according to the results of investigations conducted on previous similar instances of the fault, it is reasonable to trace the case back to a failure of the pump head.
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Search Alerts/Recalls
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