Model Number INFKIT2 |
Device Problem
Protective Measures Problem (3015)
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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 pump was not returned to mmdg for evaluation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg, an investigation could not be completed.This report is being filed for the reported delay in therapy that the patient experienced as a result of the complaint.
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Event Description
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The initial reporter stated that the pump was alarming an error code 12 and that it persisted after resetting the pump.They stated that this resulted in an approximately 6 hour delay of therapy.They did not state if the patient had an alternative method of feeding.Mmdg did follow up with the initial reporter.They reported the delay at this time, but did not provide any other information about the patient.No adverse effects were reported and no other information was provided.(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 device was returned to mmdg for investigation, the pcb board had failed causing the pump to display multiple error codes.The pump will be serviced to correct the issue.This report is being filed for the reported delay in therapy that the patient experienced as a result of the complaint.
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Event Description
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The initial reporter stated that the pump was alarming an error code 12 and that it persisted after resetting the pump.They stated that this resulted in an approximately 6 hour delay of therapy.They did not state if the patient had an alternative method of feeding.Mmdg did follow up with the initial reporter.They reported the delay at this time, but did not provide any other information about the patient.No adverse effects were reported and no other information was provided.(b)(4).
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Search Alerts/Recalls
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