BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM

    MDR report key: 13310918 · Received January 20, 2022

    Report

    Report Number
    3009897021-2022-00028
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    December 29, 2021
    Report Date
    January 20, 2022
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00849554005600
    PMA / PMN Number
    K201571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED "AMPUTATION OF THE TOES" IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL CLINICAL INFORMATION. THE DEVICE PASSED QUALITY CONTROL CHECKS BEFORE AND AFTER PATIENT PLACEMENT. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS: KEEP V.A.C.® THERAPY ON: NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY, OR APPLY AN ALTERNATIVE DRESSING AT THE DIRECTION OF THE TREATING PHYSICIAN. 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. 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. CLINICAL CONSIDERATIONS FOR DIABETIC FOOT ULCERS: AS WITH ANY TREATMENT FOR DIABETIC FOOT ULCERS, SUCCESS DEPENDS ON ACCURATE DIAGNOSIS AND THE MANAGEMENT OF UNDERLYING DISEASE IN COMBINATION WITH EFFECTIVE DEBRIDEMENT OF NON-VIABLE TISSUE. OFF-LOADING IS ESSENTIAL FOR SUCCESSFUL HEALING OF DIABETIC FOOT ULCERS. EARLY IDENTIFICATION AND PROMPT TREATMENT OF INFECTION IS ESSENTIAL TO PREVENT COMPLICATIONS. IN PATIENTS WITH DIABETES, THIS MAY BE DIFFICULT AS CLASSIC SIGNS SUCH AS PAIN, ERYTHEMA, HEAT AND PURULENCE MAY BE ABSENT OR DECREASED. SPECIAL DRESSING TECHNIQUES MAY BE CONSIDERED. DETERIORATION OF THE WOUND: 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: IF AVAILABLE ON THE THERAPY UNIT, CHECK THE THERAPY HISTORY LOG TO ENSURE 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 · 0

    ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT WAS ALLEGEDLY ADMITTED TO THE HOSPITAL FOR "AMPUTATION OF THE TOES" AND STATED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WOULD BE RESUMED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A KCI SERVICE CENTER, AND THE DEVICE PASSED AND MET SPECIFICATION. ON (B)(6) 2021, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485047 ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDARM 00849554005600

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| S