Model Number INFKIT2 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg for evaluation, an investigation could not 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 under delivered.They stated that they set the pump to infuse a dose of 100 ml and that it only delivered 13.62 ml.No other details were provided.Mmdg did attempt to follow up with the initial reporter but the attempt was unsuccessful.They did state that the complaint occurred during testing and had not had any effect on a patient.[complaint-(b)(4).
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Event Description
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The initial reporter stated that the pump under delivered.They stated that they set the pump to infuse a dose of 100 ml and that it only delivered 13.62 ml.No other details were provided.Mmdg did attempt to follow up with the initial reporter but the attempt was unsuccessful.They did state that the complaint 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 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 or 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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