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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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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.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 the pump started alarming with no disposable.Patient tried cassette on both pumps and it did the same thing.No patient injury reported.
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Search Alerts/Recalls
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