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 03/05/2020 |
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 "turns off automatically".Mmdg followed up with the initial reporter who stated that they did not have any further information.There was also no indication that the complaint occurred while the pump was in use by a patient.(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 operated as expected.Mmdg could not replicate or confirm the 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 "turns off automatically." mmdg followed up with the initial reporter who stated that they did not have any further information.There was also no indication that the complaint occurred while the pump was in use by a patient.Complaint: (b)(4).
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Search Alerts/Recalls
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