Model Number 28-95-80 |
Device Problems
No Display/Image (1183); Pumping Stopped (1503)
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Patient Problem
Death (1802)
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Event Date 11/29/2017 |
Event Type
Death
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Manufacturer Narrative
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(b)(6).Livanova (b)(4) manufactures the s5 control panel mrp 150/85.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.Functional verification testing was completed without fault.A serial readout was performed and sent to livanova (b)(4) for further evaluation.Analysis of the readout was able to confirm that the device was hand cranked, however the reported display and pump stop malfunctions could not be confirmed.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that the display of an s5 control panel mrp went blank and the pump stopped working during a procedure.The user began to hand crank and was able to restart the pump successfully after several attempts.The procedure was completed without further issues.The patient died one day after the operation of multiple organ failure.It is unknown at this time if the patient death is related to the event.
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Manufacturer Narrative
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The mast roller pump system was returned to livanova (b)(4) for detailed investigation.During the investigation, no failures could be identified.The device worked according the specification and the reported issue was not reproduced.As the issue could not be reproduced, a root cause was not identified.
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Search Alerts/Recalls
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