Model Number INFKIT2 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Event Description
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The initial reporter stated that the pump was "not alarming when food is gone" and that it "keeps pumping".The initial reporter stated that the patient had not experienced any adverse effects due to the complaint, but that they had no further information.[complaint-(b)(4)].
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Manufacturer Narrative
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This device was not returned to mmdg for evaluation.A dhr review was completed and found no non conformances.Because the device was not returned to mmdg, no investigation could be completed.This report is being filed because the event occurred while the device was in use by a pediatric patient (under 18), and will be updated if the device is returned to mmdg.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.
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Event Description
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The initial reporter stated that the pump was "not alarming when food is gone" and that it "keeps pumping".The initial reporter stated that the patient had not experienced any adverse effects due to the complaint, but that they had no further information.[complaint- (b)(4).
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Manufacturer Narrative
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This device was returned to mmdg for evaluation.A dhr review was completed and found no non conformances.When the device was returned to mmdg for investigation, the pump operated as expected.Mmdg could not replicate or confirm the reported complaint.This report was filed because the event occurred while the device was in use by a pediatric patient.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.
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Search Alerts/Recalls
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