Model Number 28-95-85 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp 85.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The processor board of the s5 double roller pump (slave pump) was replaced as precaution.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced board was returned to livanova (b)(4) facility.Visual inspection was performed on the processor board and no evidence of failure could be determined.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 that the stop-link function did not work on two pumps used on a s5 system during a procedure.In detail the "slave" pump (s5 control panel mrp 85) did not stop when the arterial pump stopped.Reportedly the symbol of the stop-link function activated was not displayed confirming that the pumps were not engaged.Powering off the controller and turning it back on improved the issue.There was no report of patient injury.
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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 most likely root cause is an intermittent failure of the processor board.
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Search Alerts/Recalls
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