LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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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 06/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in homewood, alabama.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The motor control board and motor driver board.The problem could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 received report that a s5 system displayed an error message "no monitoring/control pump".A s5 double head pump stopped, gave an audible beeping and touchscreen was not displaying time/volume delivered.The perfusionist power cycled the pump but this did not correct the problem.Perfusionist swapped the device with a spare unit and successfully completed the case.There was no patient injury.
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Manufacturer Narrative
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H.10: based on service activity findings, the root cause of the reported issue can be traced back to faulty motor controller board and motor driver board.
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Event Description
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See initial report.
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Search Alerts/Recalls
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