BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 5995117 · Received October 3, 2016

    Report

    Report Number
    3009897021-2016-00084
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    June 14, 2016
    Report Date
    May 17, 2017
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THE CORRECTION OF INFORMATION REPORTED. ALL MANUFACTURES. DATE RECEIVED BY MANUFACTURER WAS REPORTED AS: 08/22/2016. CORRECTION: 09/22/2016.

    Additional Manufacturer Narrative · 1

    VOLUNTARY REPORT NO. MW5064395 NOTED THE "EVENT DATE" AS (B)(6) 2016. IT IS UNKNOWN WHEN THE ALLEGED INFECTED VASCULAR GRAFT AND HEMORRHAGE AND SUBSEQUENT DEATH OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. NO SPECIFIC IDENTIFIERS WERE PROVIDED TO ADDRESS THE INITIAL REPORTER OR THAT WOULD ENABLE KCI TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: DRESSING CHANGES: WOUNDS BEING TREATED WITH THE V.A.C.® THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN A MONITORED, NON-INFECTED WOUND, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITH FREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS, DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON A CONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. INFECTION: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS AND INSTILLATION THERAPY PARAMETERS (FOR THE V.A.C. INSTILL® THERAPY SYSTEM). REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C.® DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C.® THERAPY SHOULD BE DISCONTINUED. GRAFT FAILURE: NEVER LEAVE A V.A.C. ® DRESSING IN PLACE WITHOUT ACTIVE V.A.C. ® THERAPY FOR MORE THAN 2 HOURS. IF THERAPY IS OFF FOR MORE THAN 2 HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY; OR APPLY AN ALTERNATIVE DRESSING AT THE DIRECTION OF THE TREATING CLINICIAN. CONTINUOUS THERAPY IS ALSO GENERALLY RECOMMENDED FOR PATIENTS AT INCREASED RISK OF BLEEDING, HIGHLY EXUDATING WOUNDS, FRESH FLAPS AND GRAFTS, AND WOUNDS WITH ACUTE ENTERIC FISTULAE. CONTINUOUS THERAPY FOR DURATION OF 7 DAYS WITH NO DRESSING CHANGES IS ALSO GENERALLY RECOMMENDED FOR USE OF V.A.C. ® THERAPY WITH A NEW GRAFT PLACEMENT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2016, KCI WAS NOTIFIED BY THE US FOOD AND DRUG ADMINISTRATION THAT THE FOLLOWING INFORMATION WAS REPORTED VIA VOLUNTARY REPORT NO. MW5064395: EVENT DATE: (B)(6) 2016. THE PHYSICIAN ALLEGED THAT THE PATIENT HAD A FEMORAL BYPASS WITH EXPANDED POLYTETRAFLUOROETHYLENE (PTFE) MATERIAL, AND A LEFT ILIAC STENT PLACEMENT IN 2016 AND DEVELOPED AN INFECTION SOON AFTER WITH STAPH AUREUS AND E. COLI PRESENT. THE WOUND WAS DEBRIDED WITH NEGATIVE PRESSURE THERAPY DEVICE USED AND A MUSCLE FLAP WAS DONE ON THE LEFT GROIN. THE PATIENT WAS EVENTUALLY DISCHARGED TO HOME ON ORAL ANTIBIOTICS, BUT WAS RE-ADMITTED FOR A POSSIBLE NEW INFECTION OF THE VASCULAR GRAFT ON THE LEFT. THE RIGHT GROIN HAD AN EXPOSED VASCULAR GRAFT, WHICH WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. ON APPROXIMATELY (B)(6) 2016, THE PATIENT HAD AN ANASTOMATIC LEAK BLEEDING EVENT ON LEFT SIDE WHILE THE NEGATIVE PRESSURE DEVICE WAS ON. SURGERY WAS DONE TO REMOVE GRAFT AND REPAIR LEAKAGE. THE PATIENT EXPIRED THE FOLLOWING DAY. THE NEGATIVE PRESSURE DEVICE WAS IN USE AT THE TIME OF THE ALLEGED EVENT AND WAS POSSIBLY RELATED TO THE INFECTED VASCULAR GRAFT AND HEMORRHAGE. THIS OCCURRED ON THE SIDE WHERE GRAFT WAS NOT EXPOSED, 75 MMHG PRESSURE WAS USED. THE WOUND V.A.C. WAS USED ON BOTH WOUNDS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT SERIAL NUMBER WAS NOT PROVIDED, THEREFORE KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645593 ACTIV.A.C.® THERAPY OMP OMP KCI USA, INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R