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Model Number 60-01-04 |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in toledo, spain.Livanova initiated an investigation.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 deutschland received a report that a centrifugal pump 5 (cp5) stopped involuntary during priming.There was no patient involvement.
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Manufacturer Narrative
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Serial read out (real time device parameters and setting recording file) of the pump was collected.The logs recorded an "index pulse missing" message, which stands for a connection issue between the panel and the drive.A tssi representative provided support about what to check and what to replace to prevent the issue from occurring.The livanova submitter reported that the equipment returned to service without showing any further deviations.Since the unit is working as intended, the customer decided not to remove the cp5 from service and ship it back to livanova for repair.The situation will continue to be monitored.A device service history review has been performed and identified that the unit was manufactured in 2022 and no other similar events have been reported.No short-term or long-term trends has been detected for the reported type of failure.Based on all the collected information, it cannot be excluded that a sporadic fault of any internal electrical component led to the reported occurrence.No other specific action was currently deemed necessary, livanova maintains and documents periodic customer events monitoring processes in order to evaluate actions for the improvement of the products.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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Event Description
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See initial report.
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Search Alerts/Recalls
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