Model Number 10-88-00 |
Device Problems
Pumping Stopped (1503); Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Sorin group (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative learned that an error was not displayed during the event and the user was able to resolve the issue by restarting the pump.The case was continued without further issue.The service representative replaced the mast mounted roller pump and control panel.Subsequent functional testing did not identify further issues and the unit was returned to service.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 (b)(4) received a report that the s5 mast roller pump stopped flowing and the speed control knob became unresponsive during a procedure.There was no report of patient injury.
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Manufacturer Narrative
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Livanova usa performed an in house investigation on the returned parts with the following results.S5 variolock tubing clamp and s5 mast roller pump were installed on the s5 test bed and tested for 3 hours at various speeds with no issues encountered with pump operation.The lower corners of the touch screen were not always responsive likely due to the spills shown in the visual inspection.Other than touch screen response, the devices operated as intended.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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Event Description
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The arterial pump head stopped flowing during cpb and the controller rpm knob was unresponsive.The pump stopped, but no error was displayed.The operator was able to power down/up and continue case without further incident.
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Search Alerts/Recalls
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