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 01/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.The device was returned to mmdg, but at the time of this report, the investigation was not completed.This report will be updated when the investigation information is available.
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Event Description
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The initial reporter stated that the pump was over infusing.They stated that the pump should have finished in about 12 hours, but that it was finishing between 1-3.5 hours early.At the time of the complaint, the initial reporter stated that the patient had not experienced any adverse effects, and that they had no further information about the complaint.Complaint: (b)(4).
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Event Description
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The initial reporter stated that the pump was over infusing.They stated that the pump should have finished in about 12 hours, but that it was finishing between 1-3.5 hours early.At the time of the complaint, the initial reporter stated that the patient had not experienced any adverse effects, and that they had no further information about the complaint.(b)(4).
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Manufacturer Narrative
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The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.When the device was returned to mmdg for investigation, it operated as expected.Mmdg could not replicate of confirm the reported complaint.Based on this information, no mdr would have been required.
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Search Alerts/Recalls
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