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 01/30/2023 |
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 under delivered.They stated that the pump was set to deliver 340 ml in one hour, but that it had not finished in that time and that the volume total stated that it had only delivered 245 ml.At the time of the complain the initial reporter stated that there had been no adverse effects to the patient and that they had no additional information.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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Event Description
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The initial reporter stated that the pump under delivered.They stated that the pump was set to deliver 340 ml in one hour, but that it had not finished in that time and that the volume total stated that it had only delivered 245 ml.At the time of the complain the initial reporter stated that there had been no adverse effects to the patient and that they had no additional information.(b)(4).
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Search Alerts/Recalls
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