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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 03/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: unknown.Device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the device exhibited an air-in-line alarm with only 50cc infused, but 100cc bag was empty.There was a patient involvement, and no patient harm/no adverse event reported.
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Manufacturer Narrative
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One device was received for evaluation.Visual inspection found a worn-out dso seal.No applicable evidence was found in the event history log.Functional testing was able to verify the reported problem.It was determined that the out of specification expulsor was the root cause and was replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.
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Search Alerts/Recalls
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