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Model Number 2110 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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One device was received for evaluation.Visual inspection found the device to be in good condition.Five 'downstream occlusion' alarms were found in the event history log.Functional testing was able to verify the reported problem.It was determined that the faulty dso sensor was the root cause and was replaced.The service history review identified no indication that the complaint was related to a service of the device within the review period.
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Event Description
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It was reported that a purge problem with a 250 ml cassette pump, causing an occlusion alarm.The alarms were recurrent and not present with 100 ml cassettes.The pump was used for iv antibiotic treatment and pca oxycodone.Troubleshooting was performed but the alarm persisted.The pump was checked with 100 ml cassettes, but no alarm was triggered.There was patient involvement and no patient harm was reported.
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Search Alerts/Recalls
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