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Device Problems
Device Alarm System (1012); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that the pump alarms ?no disposable, clamp tubing" with cassette connected.The cassette has small bubbles in the tubing exiting the hard cassette to the end.No further details provided.
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Operator of device is unknown.No information has been provided to date.
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Search Alerts/Recalls
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