Model Number 10-80-00 |
Device Problem
Failure to Pump (1502)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/17/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Sorin group deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).(b)(4).Sorin group received a report that the s5 roller pump would not start and displayed a motor control failure.This issue was discovered by a sorin representative during preventative maintenance, so there was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group received a report that the s5 roller pump would not start and displayed a motor control failure.This issue was discovered by a sorin representative during preventative maintenance, so there was no patient involvement.
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The livanova field service representative who was on-site for annual maintenance attempted to resolve the issue through replacement of the motor control board.However, the issue persisted and the entire pump head had to be replaced.The device was tested without further issue and was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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Search Alerts/Recalls
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