BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C. THERAPY SYSTEM

    MDR report key: 7547276 · Received May 27, 2018

    Report

    Report Number
    3009897021-2018-00051
    Event Type
    Injury
    Date Received
    May 27, 2018
    Date of Event
    April 25, 2018
    Report Date
    September 5, 2019
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00849554005600
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED IF THE ALLEGED FUNGAL RASH IS RELATED TO THE ACTIV.A.C.¿ THERAPY SYSTEM OR REQUIRED MEDICAL OR SURGICAL INTERVENTION TO RESOLVE.

    Description of Event or Problem · 0

    ON (B)(4) 2018, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2018, THE DEVICE WAS PLACED WITH THE PATIENT. ON 06-AUG-2019, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI QUALITY ENGINEERING AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED IF THE ALLEGED FUNGAL RASH IS RELATED TO THE ACTIV.A.C.¿ THERAPY SYSTEM OR REQUIRED MEDICAL OR SURGICAL INTERVENTION TO RESOLVE. 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

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT'S DRESSING WAS NOT REAPPLIED ON (B)(6) 2018 DUE TO A (B)(6) RASH ACROSS THE ABDOMEN. PHYSICIAN REAPPLIED THE DRESSING ON (B)(6) 2018. THE RASH EXTENDED OUTSIDE OF THE DRAPE EDGES. NO ADDITIONAL INFORMATION IS AVAILABLE. ON (B)(6) 2018, THE DEVICE PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS BEFORE PLACEMENT WITH THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE. TO DATE, THIS DEVICE REMAINS WITH THE PATIENT AND IS UNAVAILABLE FOR EVALUATION IN KCI QUALITY ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389624 ACTIV.A.C. THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDARM 00849554005600

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other