MalfunctionDPW
CO-SET+ DELIVERY SYSTEM (CARDIAC OUTPUT TUBING AND SYRINGE)
Received May 25, 2017 · Event occurred May 8, 2017
Report 6590277 · MDR key 6590277
Device
Generic name
Cardiac Output Unit, Tubing And Syringe
Manufacturer
Edwards LifesciencesCatalog number
93610
Lot number
59966174
Product problems
- Crack
- Defective Device
Patient
8 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PATIENT HAD 5 FRENCH SWAN PLACED IN CATHETER LAB AND PATIENT WAS READMITTED TO PEDIATRIC INTENSIVE CARE UNIT. WHEN ATTACHING THE CARDIAC OUTPUT TUBING, THE TUBING AND SYRINGE CRACKED TWICE AND WERE DEFECTIVE. HAD TO GET A 3RD SET UP FOR IT TO WORK.