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 05/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The pump was not returned to mmdg for evaluation.A dhr review was completed and no non conformances were found.Because the pump was not returned to mmdg, no investigation could be completed.This report will be updated if the pump is returned to mmdg.
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Event Description
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The initial reporter stated that the pump was under infusing.They stated that the feeding was programmed to deliver a 100 ml dose.They stated that the pump delivered 15 mls, then they stated that it delivered 25 mls.The initial reporter stated that the complaint occurred during testing and that no patient had been affected.(b)(4).
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Manufacturer Narrative
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The pump was returned to mmdg for evaluation.A dhr review was completed and no non conformances were found.When the pump was returned to mmdg for investigation, the initial reporter advised that they had provided an incorrect serial number.That was corrected in this report.The investigation also did show a failed motor, which resulted in the pump under infusing, however, it was still within the volumetric range that mmdg considers not reportable.
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Event Description
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The initial reporter stated that the pump was under infusing.They stated that the feeding was programmed to deliver a 100 ml dose.They stated that the pump delivered 15 mls, then they stated that it delivered 25 mls.The initial reporter stated that the complaint occurred during testing and that no patient had been affected.(b)(4).
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Search Alerts/Recalls
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