Model Number INFKIT2 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to mmdg for evaluation.A dhr was performed and no non conformances were found.Because the device was not returned, mmdg has been unable to investigate or confirm the complaint.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 "stops feeding sporadically and does not complete dose".Mmdg followed up with the initial reporter who stated that they did not have any further information.(b)(4).
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Event Description
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The initial reporter stated that the pump "stops feeding sporadically and does not complete dose".Mmdg followed up with the initial reporter who stated that they did not have any further information.Complaint: (b)(4).
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Manufacturer Narrative
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The device was returned to mmdg for evaluation.A dhr was performed and no non conformances were found.When the device was returned to mmdg for investigation, the pump did under infuse, however, it was still within the volumetric range that mmdg would consider not reportable.Based on this information, no mdr would have been required.
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Search Alerts/Recalls
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