Model Number 16-02-85 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported error codes.He traced the fault back to both patient pumps.He replaced the pumps and the issue was solved.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 (b)(4) received a report that a heater-cooler system 3t displayed two error codes associated to pumps malfunction on the patient circuit.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: through a device service history analysis livanova found out that this case is a duplicate of another event already reported under the initial medwatch # mw-007721 and follow up medwatch # mw-008196.Thus this case has been voided since the mentioned one is capturing all the above mentioned information.
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Search Alerts/Recalls
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