14.5F X 28 CM HEMO-FLOW
Received Aug 15, 2011 · Event occurred May 20, 2011
Report 2518902-2011-00078 · MDR key 2227589
Device
Product problems
- Crack
- Fluid/Blood Leak
Patient
81 YR
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "AS CATHETER WAS BEING FLUSHED PRIOR TO TREATMENT, BLOOD WAS NOTICED OOZING FROM THE CATHETER, AND MICROBUBBLES APPEARED TO BE PRESENT. CLOSER EXAMINATION REVEALED A CRACK IN THE CATHETER. THE CATHETER WAS CLAMPED AND URGENT BLOODS SENT. THE PT REQUIRED THE PLACEMENT OF A TEMPORARY FEMORAL CATHETER TO FACILITATE TREATMENT, PRIOR TO PLACEMENT OF A NEW PERMANENT CATHETER."
Additional Manufacturer Narrative
A REVIEW OF THE MFG RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED. THE ROOT CAUSE COULD NOT BE ACCURATELY DETERMINED BECAUSE THE PHYSICAL DEVICE WAS NOT RETURNED FOR A COMPLETE ANALYSIS.