Users Manual Part 1

Clinical Overview
DKPI-00061-002 was a single-center, randomized,
6-cohort, prospective study in 60 healthy adult
volunteers. The objective of the study was to assess
accuracy and reliability of the Remunity
Infusion
System while delivering normal saline. Accuracy
was assessed by weighing the Remunity Infusion
System using validated methods at specific time
points to compare the measured volumetric flow
rate to the programmed flow rate. Remunity
Infusion System reliability was assessed by
reviewing device history logs, attention alarms, and
alarms. Each subject in the study received
subcutaneous infusions of normal saline using up to
2 Remunity Infusion System pumps concomitantly.
Each pump was programmed to deliver normal
saline at 16, 35, or 100 µL/hour for up to 72 hours
depending on the subject’s assigned cohort.
Mean pump accuracy was assessed in 107 pumps
and was -1.18% (median: 1.20%, range: -5.6% to
2.6%). Throughout the study, 77 pumps contributed
618 weight measurements taken at intervals of 6
hours or less, and 30 pumps contributed weight
measurements taken after delivery of the nearly full
reservoir capacity. Of the 618 intervals with pump
accuracy calculations for pumps with interim time
point measures, 590 intervals (95.5%) had overall
pump accuracy calculations ≥-6% to ≤6%. Of the
30 pumps contributing weight measurements taken
after delivery of the nearly full reservoir capacity, all
30 intervals (100%) had overall pump accuracy
calculations ≥-6% to ≤6%. Pump reliability,
including malfunctions and complications, was
assessed in 120 pumps. Overall, 92 pumps
experienced an attention alarm/alarm during
infusion. Of the 92 pumps with attention
alarms/alarms, 30 pumps were discontinued after
experiencing the following alarms: 16 cassette
depleted alarms, 10 cassette problem alarms, 3
occlusion alarms, and 1 pump failure alarm.
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