MalfunctionNIF
HEMO- FLOW CATHETER
Received Aug 15, 2011 · Event occurred May 27, 2011
Report 2518902-2011-00079 · MDR key 2227568
Device
Product problems
- Crack
Patient
75 YR
- No Information
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE MFG RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THE DEVICE WAS IMPLANTED FOR 2 YEARS 1 MONTH. THE FACILITY WAS USING "REMOVE ADHESIVE SOLVENT WIPES." THIS SOLUTION IS NOT RECOMMENDED TO BE USED ON THIS CATHETER.
Description of Event or Problem
IT WAS REPORTED THAT "AT COMMENCEMENT OF TREATMENT, IT WAS NOTICED THAT BLOOD WAS OOZING FROM THE CATHETER. A SMALL CRACK WAS SEEN. CATHETER WAS CLAMPED. A TEMPORARY FEMORAL CATHETER WAS INSERTED TO FACILITATE TREATMENT IN ADVANCE OF THE PLACEMENT OF A PERMANENT DIALYSIS CATHETER."