INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
Received Nov 13, 2019
Report 1318360-2019-00004 · MDR key 9315277
Device
Generic name
Integrated Catch-up Freedom Syringe Driver Infusion System
Manufacturer
Repro-med Systems, Inc.Model number
FREEDOM60Lot number
S.68264
Product problems
- Inaccurate Flow Rate
- Inaccurate Flow Rate
Patient
Not reported
- Overdose
- Overdose
Narrative
Description of Event or Problem
PATIENT REPORTED TO RMS THEY INFUSE CUVITRU WEEKLY. DOSE IS 20GRAMS/100ML. UTILIZING FREEDOM60 SYRINGE DRIVER, 2400 FLOW RATE TUBING AND 24 GAUGE, 9MM NEEDLES IN TWO SITES. INFUSIONS HAVE BEEN COMPLETING IN 38-40 MINUTES. FLOW RATE CALCULATOR INDICATES INFUSION TIMES SHOULD BE 54 MINUTES.
Additional Manufacturer Narrative
ATTACHMENT: [COMPLAINT (B)(4).PDF].
Description of Event or Problem
PATIENT REPORTED TO RMS THEY INFUSE CUVITRU WEEKLY. DOSE IS 20GRAMS/100ML. UTILIZING FREEDOM60 SYRINGE DRIVER, 2400 FLOW RATE TUBING AND 24 GUAGE, 9MM IN TWO SITES. INFUSIONS HAVE BEEN COMPLETING IN 38-40 MINTUES. FLOW RATE CALCULATOR INDICATES INFUSION TIMES SHOULD BE 54 MINUTES.