LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number 10-80-00 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).To cure the fault the livanova field service engineer replaced the on-/off-switches.Subsequent functional verification testing found no further issues and the devices were returned to service.A root cause why the switches have failed, could not be determined.A review of the dhr's did not identify any deviations or nonconformities relevant to the issue.
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Event Description
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Livanova (b)(4) received a report that during the repair of the device, the power switches of an s5 roller pump identified being defective.Although it was pressed, it would return, as it was not latching.There was no patient involvement.
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Search Alerts/Recalls
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