MalfunctionDPW
EDWARDS CO-SET+
Received Jul 18, 2014 · Event occurred Jun 25, 2014
Report 3994199 · MDR key 3994199
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Edwards Lifesciences AgModel number
93610Catalog number
*
Lot number
*
Product problems
- Improper Flow or Infusion
Patient
64 YR
- No Information
Narrative
Description of Event or Problem
CARDIAC OUTPUT FLUSH TUBING DID NOT FUNCTION PROPERLY. TUBING IS DESIGNED TO NOT BACKFLOW UNLESS MANUAL PRESSURE IS APPLIED TO THE SYRINGE TO WITHDRAW FLUID. THIS WAS NOT WORKING. TUBING AND SYRINGE WERE SAVED.