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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 Type
malfunction
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Event Description
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It was reported that one pre-filled remodulin cassette from last week, and one from this week, both causing -no disposable- alarm on both pumps.Patient was unable to resolve the alarm with usual troubleshooting.No patient injury was reported.No patient injury was reported.
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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.No information has been provided to date.
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Search Alerts/Recalls
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