Model Number 8100 |
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 03/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that the pump was programmed to infuse over one (1) hour, however the medication infused in one and a half (1 1/2) to two (2) hours.There was patient involvement but no harm.
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Manufacturer Narrative
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A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
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Event Description
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It was reported that the pump was programmed to infuse over one (1) hour, however the medication infused in one and a half (1 1/2) to two (2) hours.There was patient involvement but no harm.
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Manufacturer Narrative
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Additional information : imdrf annex b code and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
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Search Alerts/Recalls
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