MalfunctionNIF
14.5FX28CM HEMO-FLOW
Received Mar 28, 2011 · Event occurred Feb 21, 2011
Report 2518902-2011-00025 · MDR key 2066079
Device
Product problems
- Crack
Patient
45 YR
- No Information
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE CATHETER DEVELOPED A "TRANSVERSE CRACK BEHIND THE CONE ON THE VENOUS LINE. THE PROBLEM OCCURRED AFTER ABOUT 45 MINUTES OF TROUBLE-FREE HEMODIALYSIS TREATMENT."