Model Number INFKIT2 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The pump 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 will be updated if the device is returned to mmdg.
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Event Description
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The initial reporter stated that the pump was over infusing.Mmdg did follow up with the initial reporter, who stated that this had occurred during testing and had not had any effect on a patient.(b)(4).
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Manufacturer Narrative
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The pump was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the device was returned to mmdg for evaluation, the pump operated as expected.Mmdg could not replicate or confirm the reported complaint.Based on this information, no mdr would have been required.
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Event Description
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The initial reporter stated that the pump was over infusing.Mmdg did follow up with the initial reporter, who stated that this had occurred during testing and had not had any effect on a patient.[complaint- (b)(4).].
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Search Alerts/Recalls
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