Model Number 21-7302-24 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient called stating that the device was exhibiting a double beeping alarm on cadd legacy pump.No alarm display noted.The cassette alarmed on both pumps.The cassette was disposed of.No further details provided.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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Manufacturer Narrative
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Operator of device is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.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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Manufacturer Narrative
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Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
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Search Alerts/Recalls
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