MalfunctionFII
MDR event
Received Nov 14, 2007
Report 9616240-2007-00107 · MDR key 976285
Device
Product problems
- Disconnection
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO PT INJURY WAS REPORTED. - IMPROVEMENTS TO INCREASE THE ROBUSTNESS OF THE HYDRAULIC CONNECTIONS HAVE BEEN DESIGNED AND VALIDATED AND ARE CURRENTLY BEING INTRODUCED IN THE FIELD TO AVOID THE OCCURRENCE OF TUBING DISCONNECTION.