BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C. THERAPY SYSTEM

    MDR report key: 10653835 · Received October 8, 2020

    Report

    Report Number
    3009897021-2020-00895
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    June 3, 2019
    Report Date
    December 18, 2020
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00878237008188
    PMA / PMN Number
    K201571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE MEDICAL REVIEW AND ASSESSMENT PERFORMED BY KCI GLOBAL SAFETY, IT WAS DETERMINED THAT THE ALLEGED INFECTION AND AMPUTATION WERE NOT RELATED TO THE ACTIV.A.C.¿ THERAPY UNIT. THE COMPLAINT REPORTS THAT THE PATIENT'S MEDICAL PROVIDERS FAILED TO COMPLY WITH THE STANDARD OF CARE INCLUDING FAILING TO PROPERLY TREAT THE PATIENT'S INFECTION AND MONITOR FOR SIGNS AND SYMPTOMS OF SKIN BREAKDOWN. THEREFORE, KCI HAS DEEMED THIS EVENT AS NOT REPORTABLE. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2020, KCI GLOBAL SAFETY PERFORMED A MEDICAL ASSESSMENT OF THE PATIENT'S CLINICAL RECORDS: THE ACTIV.A.C.¿ THERAPY SYSTEM WAS INITIATED ON (B)(6) 2019 WITH A PRE-EXISTING INFECTION AND DETERIORATING STATUS. DOCUMENTATION RECEIVED NOTED THAT THE WOUND BED HAD 25% ESCHAR AND 75% NECROTIC SLOUGH PRESENT: SIGNS AND SYMPTOMS OF INFECTION WERE PRESENT. THE AMOUNT OF NON-VIABLE TISSUE IS A CLEAR CONTRAINDICATION TO PLACEMENT OF THE DEVICE. ADDITIONALLY, THE PRESCRIBING PHYSICIAN SUBMITTED A DISCHARGE ORDER INDICATING THAT THE GOAL OF GRANULATION WITH ACTIV.A.C.¿ THERAPY WAS MET AND THAT THERE WERE NO ADVERSE EVENTS RELATED TO THE DEVICE. AN EVALUATION OF THE DEVICE IS NOT APPLICABLE AS THE EVENT WAS UNRELATED TO V.A.C.® THERAPY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE DATE OF THE EVENT IS UNKNOWN. THE PATIENT WAS DISCHARGED FROM V.A.C.® THERAPY ON (B)(6) 2019. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION AND AMPUTATION ARE RELATED TO THE ACTIV.A.C.¿ THERAPY SYSTEM. THE PATIENT HAD AN INFECTION PRIOR TO INITIATING V.A.C.® THERAPY WITH SLOUGH AND EXCHAR PRESENT IN THE WOUND. THE TREATING PHYSICIAN NOTED V.A.C.® THERAPY WAS DISCHARGED WITH DISCHARGE REASON "GOAL OF THERAPY MET."THE COMPLAINT REPORTS THAT THE PATIENT'S MEDICAL PROVIDERS FAILED TO COMPLY WITH THE STANDARD OF CARE INCLUDING BY FAILING TO PROPERLY TREAT THE PATIENT'S INFECTION AND MONITOR FOR SIGNS AND SYMPTOMS OF SKIN BREAKDOWN. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: CONTRAINDICATIONS: V.A.C.® THERAPY IS CONTRAINDICATED FOR PATIENTS WITH: NECROTIC TISSUE WITH ESCHAR PRESENT. NOTE: AFTER DEBRIDEMENT OF NECROTIC TISSUE AND COMPLETE REMOVAL OF ESCHAR, V.A.C.® THERAPY MAY BE USED. 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. 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. PRECAUTIONS: THE V.A.C.® THERAPY SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: ISCHEMIA TO THE INCISION OR INCISION AREA, UNTREATED OR INADEQUATELY TREATED INFECTION, INADEQUATE HEMOSTASIS OF THE INCISION, CELLULITIS OF THE INCISION AREA. IF A WOUND HAS BEEN PROGRESSING WELL FROM DRESSING CHANGE TO DRESSING CHANGE BUT THEN DETERIORATES RAPIDLY, CONSIDER THE FOLLOWING INTERVENTIONS AND, WHERE NECESSARY, SEEK THE GUIDANCE/EXPERTISE OF A SPECIALIST: CHECK THE THERAPY HOUR METER TO ENSURE THAT THE ACTUAL NUMBER OF THERAPY HOURS RECEIVED MATCHES THE NUMBER OF RECOMMENDED THERAPY HOURS (22 HOURS A DAY). IF THE NUMBER OF THERAPY HOURS IS LESS THAN 22 EACH DAY, FIND OUT WHY THERE IS A THERAPY DEFICIT AND REMEDY THE SITUATION. CLEAN WOUND MORE THOROUGHLY DURING DRESSING CHANGES. EVALUATE FOR SIGNS AND SYMPTOMS OF INFECTION AND, IF PRESENT, TREAT ACCORDINGLY. CHANGE DRESSING OFTEN, ENSURING THAT IT IS BEING CHANGED AT LEAST EVERY 48 HOURS. EXAMINE THE WOUND AND DEBRIDE AS NECESSARY. DEBRIDE THE WOUND EDGES IF THEY APPEAR NON-VIABLE OR ROLLED UNDER AS THIS MAY INHIBIT THE FORMATION OF GRANULATION TISSUE AND MIGRATION OF EPITHELIAL CELLS OVER AN ACCEPTABLE WOUND BASE.

    Description of Event or Problem · 1

    PER A REVIEW OF KCI RECORDS: ON (B)(6) 2019, PRIOR TO INITIATING V.A.C.® THERAPY, IT WAS NOTED THAT THE PATIENT'S WOUND HAD SIGNS AND SYMPTOMS OF INFECTION PRESENT, WITH MILD ODOR, WELL DEFINED WOUND MARGINS, WOUND BED APPEARANCE IS OPAQUE/TAN WITH 51 TO 75 PERCENT SLOUGH AND 1 TO 25 PERCENT ESCHAR. THERE WAS NO GRANULATION OR EPITHELIALIZATION NOTED. ON (B)(6) 2019, THE PATIENT WAS PLACED ON THE ACTIV.A.C.¿ THERAPY SYSTEM. ON (B)(6) 2019, THE PATIENT'S WOUND PROGRESS WAS NOTED AS "DETERIORATING" WITH STRONG ODOR, WOUND BED APPEARANCE IS OPAQUE/TAN WITH 51 TO 75 PERCENT SLOUGH AND 1 TO 25 PERCENT ESCHAR. ON (B)(6) 2019, THE PATIENT ALLEGED THE ACTIV.A.C.¿ THERAPY SYSTEM WAS NOT WORKING. THE PATIENT REPORTED HAVING HAD AN AMPUTATION. ON (B)(6) 2019, THE PHYSICIAN PROVIDED DISCHARGE ORDERS FOR THE PATIENT THAT NOTED ON (B)(6) 2019 V.A.C.® THERAPY DISCHARGED WITH DISCHARGE REASON OF "GOAL OF THERAPY MET." KCI WAS NOTIFIED ON 08-SEP-2020, THAT A COMPLAINT HAD BEEN FILED IN CIRCUIT COURT (B)(6) ON (B)(6) 2020. THE COMPLAINT ALLEGES THAT THE ACTIV.A.C.¿ THERAPY SYSTEM MALFUNCTIONED APPROXIMATELY ONE WEEK AFTER INITIAL PLACEMENT AND AS A RESULT OF A DEFECT IN THE DEVICE AND ITS INSTRUCTIONS, THE PATIENT UNDERWENT A BELOW KNEE AMPUTATION. THE COMPLAINT ALSO ALLEGES THAT THE PATIENT'S MEDICAL PROVIDERS FAILED TO COMPLY WITH THE STANDARD OF CARE INCLUDING BY FAILING TO PROPERLY TREAT THE PATIENT'S INFECTION AND MONITOR FOR SIGNS AND SYMPTOMS OF SKIN BREAKDOWN. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ THERAPY SYSTEM IS CURRENTLY PENDING COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118135 ACTIV.A.C. THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT 00878237008188

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention| S AMLODIPINE - 10 MG| ASPIRIN - 81 MG| CARVEDILOL - 12.5 MG| FERROUS SULFATE - 325 MG| GLIMEPIRIDE - 4MG| HUMALOG MIX 75-25 KWIKPEN - 100UNIT/ML| HYDROCHLOROTHIAZIDE - 25 MG| IOSARTAN - 50 MG| ISOSORBIDE MONONITRATE - 30 MG| JANUVIA 100 MG| LEVOTHYROZINE - 50 MCG| MELOZICAM - 15 MG| METFORMIN - 500 MG| OMEPRAZOLE - 40 MG| PLAVIX - 75 MG| PROAIR HFA - 90MCG| XANAX 0.5 MG| ZOCOR - 20 MG