ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED BLEEDING EVENT IS RELATED TO THE ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING. THE DEVICE PASSED QUALITY CONTROL CHECKS AND MET SPECIFICATIONS BEFORE AND AFTER PATIENT PLACEMENT. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: CONTRAINDICATIONS DO NOT PLACE FOAM DRESSINGS OF THE V.A.C.® THERAPY SYSTEM DIRECTLY IN CONTACT WITH EXPOSED BLOOD VESSELS, ANASTOMOTIC SITES, ORGANS, OR NERVES. WARNINGS BLEEDING: WITH OR WITHOUT USING V.A.C.® THERAPY, CERTAIN PATIENTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PATIENTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL: PATIENTS WHO HAVE WEAKENED OR FRIABLE BLOOD VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTOMOSIS OR GRAFTS) / ORGAN INFECTION. TRAUMA. RADIATION. PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS. PATIENTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS. PATIENTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES. IF V.A.C.® THERAPY IS PRESCRIBED FOR PATIENTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING V.A.C.® THERAPY, OR IF FRANK (BRIGHT RED) BLOOD IS SEEN IN THE TUBING OR IN THE CANISTER, IMMEDIATELY STOP V.A.C.® THERAPY, LEAVE DRESSING IN PLACE, TAKE MEASURES TO STOP THE BLEEDING AND SEEK IMMEDIATE MEDICAL ASSISTANCE. THE V.A.C.® THERAPY UNITS AND DRESSINGS SHOULD NOT BE USED TO PREVENT, MINIMIZE OR STOP VASCULAR BLEEDING. PROTECT VESSELS AND ORGANS: ALL EXPOSED OR SUPERFICIAL VESSELS AND ORGANS IN OR AROUND THE WOUND MUST BE COMPLETELY COVERED AND PROTECTED PRIOR TO THE ADMINISTRATION OF V.A.C.® THERAPY. ALWAYS ENSURE THAT V.A.C.® FOAM DRESSINGS DO NOT COME IN CONTACT WITH VESSELS OR ORGANS. USE A THICK LAYER OF NATURAL TISSUE SHOULD PROVIDE THE MOST EFFECTIVE PROTECTION. IF A THICK LAYER OF NATURAL TISSUE IS NOT AVAILABLE OR IS NOT SURGICALLY POSSIBLE, MULTIPLE LAYERS OF NON-ADHERENT DRESSING MATERIAL MAY BE CONSIDERED AS AN ALTERNATIVE, IF DEEMED BY THE TREATING PHYSICIAN TO PROVIDE A COMPLETE PROTECTIVE BARRIER. IF USING NON-ADHERENT MATERIALS, ENSURE THEY ARE SECURED IN A MANNER THAT WILL MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

ON (B)(6) 2026, THE FOLLOWING INFORMATION WAS REPORTED BY THE PATIENT: THE ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING WAS PUMPING SO HARD IT TORE OFF THE CAUTERIZATION. AFTER IT WAS ON FOR TWO DAYS, THE PATIENT STARTED HEMORRHAGING. ON (B)(6) 2026, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: THE PATIENT WAS SEEN IN THE ER FOR BLEEDING UNDER THE V.A.C.® DRESSING. IT IS UNKNOWN WHETHER V.A.C.® THERAPY CONTRIBUTED TO THE INCIDENT. MANUAL COMPRESSION AND ADMINISTRATION OF EPINEPHRINE WERE UTILIZED TO STOP THE BLEEDING. AN ALTERNATIVE DRESSING WAS APPLIED, AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2026, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2026, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2026, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER AND THE DEVICE PASSED AND MET SPECIFICATIONS AFTER PATIENT PLACEMENT. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.