Model Number 21-7322-24 |
Device Problem
Failure to Infuse (2340)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient was receiving milrinone.Milrinone didn't infuse from (b)(6) 2022 to (b)(6) 2022.No patient injury was reported.
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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.Lot/serial number not provided.
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Manufacturer Narrative
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H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No lot number was provided; therefore, device history review could not be performed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
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Search Alerts/Recalls
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