Model Number 816571 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The reported issue was discovered when the fsr was troubleshooting the related complaint.Per fsr, he attempted to start the roller pump without tubing but the pump never started and would display an error message.These error messages were only displayed on the roller pump and did not have an audible alarm.A new pump was installed.The unit operated to the manufacturer's specifications.Data logs were returned to the manufacturer on 01-jun-2018.The suspect device was returned to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #: 1828100-2018-00318.
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Event Description
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It was reported that during the use of the device for a non-clinical activity, the roller pump would not start and displayed one of the following messages: 'pump jam', 'motor error', or 'service pump'.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.The service repair technician (srt) was unable to duplicate the reported complaint.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) could not confirmed the reported issue.The roller pump functioned normally throughout the evaluation.Per log analysis on (b)(6) 2018, each time the large roller pump was started it stops with a motor fault, or a belt slip jam status = true.The log confirms the complaint.
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Search Alerts/Recalls
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