inforMED
MalfunctionMAL

HEMASHIELD PLATINUM

Received Jan 17, 2014 · Event occurred Jan 8, 2014

Report 3602749 · MDR key 3602749

Device

Generic name

Prothesis, Vascular Graft

Model number

M00202175208P0

Catalog number

175208P

Lot number

25073824

Product problems

  • Fluid/Blood Leak

Patient

64 YR

  • Hemorrhage/Blood Loss/Bleeding
  • Blood Loss

Narrative

Description of Event or Problem

AN 8MM HEMASHIELD PLATINUM USED FOR RIGHT AXILLARY GRAFT. THE GRAFT BLED THROUGH, THE MATERIAL WAS QUITE PERMEABLE MUCH MORE THAN THE 8 HEMASHIELD THAT WAS USED THE PRIOR CASE. VERY POROUS AND WEEPY. ADDITIONAL BLOOD NEEDED TO BE GIVEN TO KEEP UP WITH THE LOSSES FROM THE GRAFT.====================== MANUFACTURER RESPONSE FOR VASCULAR GRAFT, HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT (PER SITE REPORTER).====================== THEY WILL MAKE A REPORT.