Model Number 10-80-00 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and he could not confirm the reported issue.The device was found to be working according to the specifications.Through follow-up communication livanova (b)(4) learned that the pump stopped after giving 1 liter of cardioplegia solution.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Further information has been requested in order to clarify the reported event.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 tubing has gotten stuck in the pump head of a s5 roller pump multiple times after giving 1000ml cardioplegia solution.The user stated that the occlusion was properly checked.There was no report of patient injury.
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Manufacturer Narrative
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H.10: it is reasonable to assume that the reported event has been caused by an inappropriate occlusion set by the user.Moreover, it cannot be ruled out that the cardioplegia was operated in the "automatic" mode, that leads to an automatic pump stop when the cardioplegia set volume has been delivered.
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Event Description
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See initial report.
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Search Alerts/Recalls
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