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 05/19/2022 |
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 not delivering correctly.They stated that it was both over and under, but that it was not accurate.The rate, dose, and amount delivered that they provided indicates that the pump may have infused at a rate that mmdg would consider reportable.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.No other information was provided.(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 investigation, it 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 not delivering correctly.They stated that it was both over and under, but that it was not accurate.The rate, dose, and amount delivered that they provided indicates that the pump may have infused at a rate that mmdg would consider reportable.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.No other information was provided.(b)(4).
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Search Alerts/Recalls
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