HEMO-FORCE

Description of Event or Problem

ACCORDING TO THE FACILITY, ON 5/5/2026, CVICU NURSE MANAGER (B)(6), RN AT (B)(6) HOSPITAL REPORTED THAT THEY HAVE A PATIENT WHO WAS WEARING OUR MEDIUM SEQUENTIAL DVT SLEEVE AND EXPERIENCED DTI. WOUNDS APPEARED ON THE LOWER LEGS AND THE SLEEVE WAS REMOVED. I MET WITH THE REPORTING NURSE, AND THE INTERPRETATION IS THE PATIENT HAD WOUNDS ALREADY ON THE LEGS HOWEVER THE TUBING MAY HAVE CONTRIBUTED TO IT BECAUSE OF THE SLEEVE PLACEMENT.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, ON 5/5/2026, CVICU NURSE MANAGER (B)(6), RN AT (B)(6) HOSPITAL REPORTED THAT THEY HAVE A PATIENT WHO WAS WEARING OUR MEDIUM SEQUENTIAL DVT SLEEVE AND EXPERIENCED DTI. WOUNDS APPEARED ON THE LOWER LEGS AND THE SLEEVE WAS REMOVED. I MET WITH THE REPORTING NURSE, AND THE INTERPRETATION IS THE PATIENT HAD WOUNDS ALREADY ON THE LEGS HOWEVER THE TUBING MAY HAVE CONTRIBUTED TO IT BECAUSE OF THE SLEEVE PLACEMENT. THERE WAS NO ADDITIONAL FOLLOW-UP NEEDED. NO ADDITIONAL INFORMATION AT THIS TIME. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.