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Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Udi information is unknown.Premarket (510k) number is unknown.No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Event Description
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It was reported that one of cadd legacy pumps, had two cadd cassettes in a row that have alarmed steady beeping, or no disposable and replacement pump requested.Also, one cassette is not working on all pumps.Pumps replaced.No patient injury reported.
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Search Alerts/Recalls
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