BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.¿ THERAPY SYSTEM

    MDR report key: 7349782 · Received March 19, 2018

    Report

    Report Number
    3009897021-2018-00018
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    February 17, 2018
    Report Date
    March 19, 2018
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00878237008188
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, KCI IS UNABLE TO DETERMINE IF THE PATIENT'S HOSPITALIZATION OR ALLEGED INFECTION IS RELATED TO THE USE OF ACTIV.A.C.¿ THERAPY SYSTEM. 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, 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. 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. ENSURING DRESSING INTEGRITY IT IS RECOMMENDED THAT A CLINICIAN OR PATIENT (IN THE HOME) VISUALLY CHECK THE DRESSING EVERY TWO HOURS TO ENSURE THAT THE FOAM IS FIRM AND COLLAPSED IN THE WOUND BED WHILE THERAPY IS ACTIVE. MAINTAINING A SEAL. FOR DELICATE PERIWOUND TISSUE OR IN AREAS THAT ARE DIFFICULT TO DRESS, APPLY PROTECTIVE SKIN PREPARATION AND FRAME THE WOUND WITH TRANSPARENT FILM OR HYDROCOLLOID DRESSING OR OTHER APPROPRIATE BARRIER. POSITION THE DRESSING TUBING ON FLAT SURFACES AND AWAY FROM THE PERINEAL AREA, BONY PROMINENCES OR PRESSURE AREAS.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A POSSIBLE WOUND INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: IT COULD NOT BE DETERMINED IF THE KCI¿ MEDICAL DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S HOSPITALIZATION OR WOUND INFECTION. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS ON AN ALTERNATE DRESSING. THE WOUND IS PROGRESSING WELL AND THE NURSE HAS REACHED OUT TO THE PHYSICIAN TO SEE IF V.A.C.® THERAPY WILL BE RESTARTED. ON JAN 03 2018, THE DEVICE PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS BEFORE PLACEMENT WITH THE PATIENT. ON (B)(6) 2018, THE DEVICE WAS PLACED WITH THE PATIENT. ON FEB 26 2018, THE DEVICE WAS TESTED BY KCI QUALITY ENGINEERING PER QC PROCEDURES AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191036 ACTIV.A.C.¿ THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT 00878237008188

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O