Model Number 10-60-00 |
Device Problems
Failure to Pump (1502); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/29/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the sorin s3 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 the pump was used in a case two hours earlier without incident.Before the error occurred, the customer reported to have left the pump on at 0 rpms before attempting to start.Inspection of the device found that the front panel was damaged and the speed adjustment knob was rattling.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 when the user attempted to start the s3 roller pump, it did not start and an error message was displayed.The pump was restarted and the issue was resolved.The surgery was performed without further incident.However, the pump was removed from service following the completion of the case.There was no report of patient injury.
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Manufacturer Narrative
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Through follow-up communication with the service representative, sorin group (b)(4)learned that the front panel could not be replaced at the time of service, as there were none in stock.The service representative plans to return to the facility to replace the front panel in the near future.
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Search Alerts/Recalls
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