Model Number 10-88-60 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.On-site service not yet provided.
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Event Description
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Livanova (b)(4) received a report that roller head of the s5 mast roller pump overheated and displayed a "work load exceeded" error during a procedure.The pump was switched out to continue the procedure.There was no report of patient injury.
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Manufacturer Narrative
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Microbiological sampling identified a high level of contamination of the unit: mycobacteria could not be identified but its presence can not be excluded.The customer has planned to return the device to livanova (b)(4) for the deep disinfection procedure.The customer has stated that the cleaning and disinfection procedure has been performed according to the instructions for use (ifu) and that the heater-cooler device was placed inside the operating room during use.Corrective actions are in progress for this issue.
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Manufacturer Narrative
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A livanova service representative was dispatched to the facility to investigate.The service representative was able to reproduce the reported error during testing.It was reported that the pump became too hot to touch after 30 minutes of use.The mast roller pump was replaced to resolve the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced pump was requested for investigation.However, the device was not made available and no investigation could be performed.
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Event Description
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See initial mdr.
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Search Alerts/Recalls
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