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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 03/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 cassettes, 52ml into infusion, started alarming -no disposable clamp tubing-, then steady beeping with troubleshooting.When same cassette was placed on the back-up pump, it started steady double beeping.Unable to resolve until they changed to new cadd cassette prefilled.No patient injury was reported.
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Search Alerts/Recalls
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