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It was reported that a nurse replaced a high dose fentanyl pca syringe in the pump and an overinfusion occurred.A common practice is to use the restore function when switching out syringes, which is supposed to revert the pump back to the previous drug, concentration, and rate.In this case, the nurse reports it changed settings back to the regular ¿ not high dose ¿ concentration.The entire high concentration fentanyl pca of 2500 mcg/50 ml ran over 5 hours in the icu instead of the intended rate of 125 mcg/hr (20 hours).The patient required an increased rate of the infusing vasopressors for a short period of time.The patient was already intubated.The customer indicated no further information is available.The customer requested assistance determining if the restore function was used on the pump.
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The report of a pca over infusion was confirmed and attributed to a programming error, identified during a review of the system logs.Internal and external inspection of the returned pca module observed the source device with unknown film contaminants on the male iui connector pins.No other obvious issues or anomalies were identified during the inspection of the unit.Based on log analysis results, four fentanyl infusions were programmed during the time of the reported event.At 7:11 am, the user manually programmed a pca continuous infusion of fentanyl 500mcg/50ml (drug id 321).The user selected the therapy type of pca / high dose and confirmed a soft guardrails max limit to proceed.The infusion rate was programmed at 12.5 ml/h with a vtbi of 5.2046 ml and started.The pvi was recorded as 5.2518 ml.A near end of infusion alert alarmed seconds after the infusion was started.At 7:34 am, the user manually programed the pca with the same drug name and parameters, excluding the vtbi which was recorded as 49.3832 ml.Once programmed, the infusion was started.At 11:04 am, the pca alarmed for near end of infusion.A few minutes later the user attempted to program the previous infusion, however, it was not completed.At 11:12 am, the user programed the previous infusion on the pca with the same drug name and parameters, excluding the vtbi which was recorded as 4.0982 ml.Once programmed, the infusion was started.A near end of infusion alert alarmed seconds after the infusion was started.At 11:17 am, the user attempted to program the previous infusion, however, it was not completed.At 11:19 am, the user manually programmed a pca continuous infusion with a different drug fentanyl 2500mcg/50ml (drug id 324).The user selected a different therapy type ¿continuous drip¿.The infusion rate was programmed at 2.5 ml/h with a vtbi of 3.4672 ml and started.A near end of infusion alert alarmed seconds after the infusion was started.The user cleared the volume infused (pvi= 56.414 ml).At 12:42 pm, the pca module alarmed for an empty syringe (pvi= 3.4672 ml).Total calculated volume infused was recorded as 54.624 ml.Test results derived from a functional test and asm accuracy tests demonstrated the pca module operating within specification.Functional testing programmed with the incident parameters showed no obvious issues or anomalies with the functionality of the returned device.The root cause of the over infusion of fentanyl was determined to be user programming.Device history: review of the source pca module s/n: (b)(6) service history record showed that the device was manufactured on 12/17/2014.A review of the device service history record was performed beginning from the date of manufacture to the present date 12/10/2020 and indicated that this device has not been returned to service.Review of the production failure record was performed beginning from the date of manufacture through present.No production failure records were opened for the source device.
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It was reported that a nurse replaced a high dose fentanyl pca syringe in the pump and an overinfusion occurred.A common practice is to use the restore function when switching out syringes, which is supposed to revert the pump back to the previous drug, concentration, and rate.In this case, the nurse reports it changed settings back to the regular ¿ not high dose ¿ concentration.The entire high concentration fentanyl pca of 2500 mcg/50 ml ran over 5 hours in the icu instead of the intended rate of 125 mcg/hr (20 hours).The patient required an increased rate of the infusing vasopressors for a short period of time.The patient was already intubated.The customer indicated no further information is available.The customer requested assistance determining if the restore function was used on the pump.
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