BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.¿ THERAPY SYSTEM

    MDR report key: 7264031 · Received February 12, 2018

    Report

    Report Number
    3009897021-2018-00008
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    January 9, 2018
    Report Date
    February 12, 2018
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00878237008188
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    VFSR04103: (B)(4), LOT NUMBER 3924915: (B)(4), LOT NUMBER WF17030L1S: (B)(4). PMA/510(K)NUMBER: VFSR04103: K063692, LOT NUMBER 3924915: K133276, LOT NUMBER WF17030L1S: K133276. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED FUNGAL INFECTION IS RELATED TO THE ACTIV.A.C.¿ THERAPY SYSTEM, THE V.A.C.® DRAPE OR DRESSINGS. THE PATIENT REPORTED RECEIVING DRESSING CHANGES 2 TIMES A WEEK. PER KCI RECOMMENDATIONS, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK. THIS REPORT IS BEING FILED AS POSSIBLE USE ERROR. 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. 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.

    Description of Event or Problem · 1

    ON JAN 18 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT ALLEGEDLY EXPERIENCED A MILD TO MODERATE YEAST RASH UNDER THE V.A.C.® DRAPE AND INQUIRED IF THE V.A.C.® DRAPE COULD CAUSE THE YEAST INFECTION IF IT WAS IN PLACE FOR A LONG PERIOD OF TIME. THE PATIENT REPORTED DRESSING CHANGES OCCUR TWICE A WEEK. ON JAN 23 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ACTIV.A.C.¿ THERAPY WAS BELIEVED TO HAVE CONTRIBUTED TO THE PATIENT¿S FUNGAL INFECTION. THE FUNGAL INFECTION WAS TREATED WITH A TOPICAL ANTIFUNGAL CREAM AND IS IMPROVING. PER REVIEW OF KCI RECORDS, THE PATIENT¿S WOUND WAS ASSESSED ON (B)(6) 2018. THE TISSUE WAS NOTED AS ¿SLIGHT YEAST MEDICAL SKIN SIDE OF WOUND,¿ AND BOTH DRESSINGS (1 WHITE, 1 BLACK) WERE CHANGED. DEVICE HISTORY REVIEWS WERE PERFORMED FOR VA.C.® WHITEFOAM¿ DRESSING LOT NUMBER WF17030L1S AND V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 3924915 AND DETERMINED ALL END RELEASE TESTING OF THE PRODUCTS AND PACKAGING MET SPECIFICATIONS. ON AUG 09 2017, THE ACTIV.A.C.¿ DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2017, THE ACTIV.A.C.¿ DEVICE WAS PLACED WITH THE PATIENT. ON FEB 01 2018, THE ACTIV.A.C.¿ DEVICE WAS TESTED PER QC PROCEDURE BY KCI QUALITY ENGINEERING, AND UNIT PASSED THE QC CHECKS 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
    108947 ACTIV.A.C.¿ THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT WF17030L1S, 3924915 00878237008188

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention