MalfunctionFPA
INFUSET 930 RATE TUBING
Received Apr 12, 2019 · Event occurred Apr 9, 2019
Report MW5085862 · MDR key 8515231
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Emed Technologies CorporationProduct problems
- Excess Flow or Over-Infusion
Patient
57 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PT INFUSED SUBQ HIZENTRA DOSE OVER 15 MINS, HOWEVER, THE CALCULATED INFUSION PER VERSARATE CALCULATOR SHOULD HAVE LASTED ROUGHLY 2 HOURS. PT INFUSED USING INFUSET 930 TUBING AND SCIG60 PUMPS. INFUSION WAS DONE WITH NURSE ON HAND ADMINISTERING THE INFUSION. INTEGRATED MEDICAL SYSTEMS. FDA SAFETY REPORT ID# (B)(4).