BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIV.A.C. THERAPY

    MDR report key: 3928708 · Received June 30, 2014

    Report

    Report Number
    3009897021-2014-00091
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN'S EVAL REPORTED THAT "UNTIL THE PT'S STATUS CHANGE, NO OBVIOUS CLINICAL MANIFESTATION OF FOLLOWING: DETERIORATION OF INFECTION AND TOTAL CONDITIONS OF THE PT. AFTER THE CHANGE OF PT'S STATUS, THE CAUSE OF SEPSIS WAS UNABLE TO IDENTIFY THE SITE OF INFECTION. THEREFORE, THE CAUSAL RELATIONSHIP WITH SEPSIS AND V.A.C. THERAPY WERE UNK. BESIDES THE WOUND, THE POSSIBLE SITE FOR INFECTION WOULD BE FOLLOWING: CHEST X-RAY INDICATED SIGNIFICANT DECREASE IN PERMEABILITY, SPUTUM CULTURE SHOWED GRAM-POSITIVE COCCUS, GRAM-POSITIVE BACILLUS, GRAM-NEGATIVE COCCUS, AND GRAM-NEGATIVE BACILLUS. THERE WAS A POSSIBILITY OF PNEUMONIA. HOWEVER, THE IMAGE WAS TAKEN AFTER THE PT'S SUDDEN STATUS CHANGE, THERE WAS A POSSIBILITY OF ACUTE RESPIRATORY DISTRESS SYNDROME, AND IT WAS UNABLE TO DETERMINE". ON (B)(6) 2014, V.A.C. THERAPY WAS APPLIED, AND IT WAS NOTED THAT, "THE WOUND INFECTION WAS CALMING DOWN AND CONSIDERED THE INFECTION STAGE AT THIS TIME WAS CLINICAL COLONIZATION. CONTINUED TEICOPLANIN ADMINISTRATION". THE PT'S WOUND CULTURES PRIOR AND DURING V.A.C. THERAPY ALONG WITH THE MULTIPLE BLOOD TESTS AND ANTIBIOTIC ADMIN EXHIBITED A PRE-EXISTING AND ONGOING INFECTION. IT WAS ALSO NOTED THAT, "THE PT WAS ON HEMODIALYSIS AND EXPECTED TO BE EASILY BLEEDING. DEBRIDEMENT WAS UNABLE TO PERFORM ACTIVELY AND REMOVED SMALL AMOUNT EVERY TIME". THEREFORE, THE PT'S WOUND INFECTION AND DEBRIDEMENTS WERE UNRELATED TO V.A.C. THERAPY. BASED ON THE INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE SEPSIS OR PT DEATH IS RELATED TO V.A.C. THERAPY. THE CAUSE OF THE SEPSIS IS UNK. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS. 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. ON (B)(6) 2014, THE DEVICE WAS TESTED PER QC PROCEDURE BY KCI (B)(4) SERVICE CENTER, AND THE UNIT PASSED THE QC CHECKS AND MET SPECS PRIOR TO PT PLACEMENT. ON (B)(6) 2014, THE DEVICE WAS TESTED PER QC PROCEDURE BY KCI (B)(4) SERVICE CENTER, AND THE UNIT PASSED THE QC CHECKS AND MET SPECS AFTER PT PLACEMENT. NO REPAIRS WERE REQUIRED.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE KCI (B)(4) REP: THE PHYSICIAN REPORTED THAT ON (B)(6), 2014, POST OPERATIVE TOE AMPUTATION, THE WOUND CLOSURE WAS POOR AND THERE WAS HEALING DIFFICULTY. "BETWEEN THE DIGITS SUTURE SITE 3X2CM AND BOTTOM OF THE FOOT 0.5X0.5CM SKIN DEFICIT NOTED. REMAINED DEEP NECROTIC TISSUE IN THE WOUND." V.A.C. THERAPY WAS STARTED. IT WAS REPORTED THAT THE PT WAS PRONE TO BLEEDING AND DEBRIDEMENTS WERE UNABLE TO ACTIVELY BE PERFORMED AND ONLY SMALL AMOUNT OF NECROTIC TISSUE WERE REMOVED EACH TIME. "THE WOUND INFECTION WAS CALMING DOWN AND CONSIDERED THE INFECTION STAGE AT THIS TIME WAS CLINICAL COLONIZATION. CONTINUED TEICOPLANIN ADMINISTRATION. ON (B)(6) 2014, THE SIZE OF THE WOUND CHANGED BETWEEN THE FOOT DIGITS TO BOTTOM OF THE FOOT 2.5X8X1CM." A DEBRIDEMENT WITH SUTURE REMOVAL WAS PERFORMED, AND NO OBVIOUS OPAQUE DRAINAGE OR DETERIORATION OF INFECTION WAS NOTED. ON (B)(6) 2014, A DEBRIDEMENT WAS PERFORMED. IT WAS NOTED THAT "NO INCREASED INFLAMMATORY LAB RESULTS", AND THE PT WAS AFEBRILE. ON (B)(6) 2014, A DEBRIDEMENT WAS PERFORMED, AND "THE AREA OF EXPOSING GRANULATION TISSUE OBSERVED IMPROVEMENT". ON (B)(6) 2014, THE PT STARTED SHIVERING WITH A BODY TEMPERATURE OF 39 DEGREE C, DECREASED BLOOD PRESSURE APPROX 70, 82% OXYGEN SATURATION, AND V.A.C. THERAPY WAS REMOVED. IT WAS NOTED THAT THERE WAS NO IN THE STATUS OF THE WOUND. OXYGEN WAS ADMINISTERED AT 5 LITERS/MIN, BUT NO IMPROVEMENT WAS NOTED. NONINVASIVE POSITIVE PRESSURE VENTILATION WAS STARTED. "ACUTE RESPIRATORY DISTRESS SYNDROME, DEEMED SEPTIC SHOCK". CEFTAZIDIME HYDRATE WAS ADMINISTERED. A CHEST X-RAY SHOWED SIGNIFICANT DECREASE IN PERMEABILITY. THE PT RECEIVED EMERGENCY DIALYSIS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT WHERE A CENTRAL VENOUS CATHETER WAS INSERTED, VASOPRESSORS WERE ADMINISTERED, AND NO DECREASED LEVEL OF CONSCIOUSNESS WAS NOTED. ON (B)(6) 2014, THE PT'S LEVEL OF CONSCIOUSNESS DECREASED, AND THE PT STOPPED BREATHING. THE CARDIAC MONITOR INDICATED PULSELESS ELECTRICAL ACTIVITY, AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. AT 11:18 AM, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378967 ACTIV.A.C. THERAPY OMP KCI USA INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death TEICOPLANIN DOSAGE UNK: (B)(6), 2014