MalfunctionPKP
INTEGRATED CATCH-UP FREEDOM SYRINGE DRIVER INFUSION SYSTEM
Received Mar 31, 2020
Report 1318360-2020-00001 · MDR key 9905477
Device
Generic name
Integrated Catch-up Freedom Syringe Driver Infusion System
Manufacturer
Repro-med Systems, Inc Dba Koru Medical SystemsModel number
FREEDOMEDGECatalog number
F10020
Lot number
E.79669
Product problems
- Infusion or Flow Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A PATIENT WAS ABLE TO START AN INFUSION OMMITTING THE USE OF FLOW RATE TUBING AND DIRECTLY CONNECTING THE NEEDLE SET TO THE SYRINGE WHILE UTILIZING THE FREEDOMEDGE SYRINGE DRIVER.