Catalog Number 2420-0007 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set there were air bubbles.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: problem: the pump kept reading ¿air in line¿, tubing was primed/flushed multiple times and even tried on a new iv pump but continued to read ¿air in line¿.They replaced the tubing with new tubing and it worked fine after.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set there were air bubbles.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: problem: the pump kept reading ¿air in line¿, tubing was primed/flushed multiple times and even tried on a new iv pump but continued to read ¿air in line¿.They replaced the tubing with new tubing and it worked fine after.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 10-feb-2023.H6: investigation summary one used sample model# 2420-0007, lot# 22085241 was returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed with normal saline.An infusion was performed at a rate of 125 ml/hr for 1 hour.No air was observed during or after the run.The customer complaint that the tubing had air in the line was unable to be replicated.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model 2420-0007 lot number 22085241 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Search Alerts/Recalls
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