Model Number 21-7302-24 |
Device Problem
Failure to Infuse (2340)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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.Operator of device is unknown.No information has been provided to date.
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Event Description
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It was reported that the medication was not infusing.The user complained feeling like she has no medication.No patient injury was reported.
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Manufacturer Narrative
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No product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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Search Alerts/Recalls
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