Device Problems
Device Sensing Problem (2917); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that the disposable cassette caused the pump exhibited a no disposable alarm and constant beeping.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.Udi was unknown.No product information has been received to date.Operator of device was unknown.No information has been received to date.
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Manufacturer Narrative
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H6: event problem and evaluation codes: updates not required.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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