BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12442677 · Received September 8, 2021

    Report

    Report Number
    3009897021-2021-00217
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 2, 2021
    Report Date
    October 1, 2021
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    UDI-DI
    00849554005600
    PMA / PMN Number
    K201571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR-3009897021-2021-00217 SUBMITTED ON 08-SEP-2021 NOTED THE FOLLOWING: D2 COMMON DEVICE NAME: ACTIVAC REMOTE MONITORING. CORRECTION: D2 COMMON DEVICE NAME: OMP, PRODUCT CODE: OMP. H3: OTHER (CODE UNSPECIFIED, DESCRIBE IN H10): DEVICE WAS NOT RETURNED. BASED ON ADDITIONAL INFORMATION PROVIDED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED BLEEDING EVENT IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THE DEVICE MET SPECIFICATIONS BEFORE PATIENT PLACEMENT. THE PATIENT DECLINED TO RETURN THE DEVICE; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    ON (B)(6) 2021, 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) 2021, THE DEVICE WAS PLACED WITH THE PATIENT. THE PATIENT DECLINED TO RETURN THE DEVICE; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED BLEEDING EVENT IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THE PATIENT HAD BLOOD CLOTS IN THE WOUND PRIOR TO V.A.C.® THERAPY AND WAS ON ANTICOAGULANT MEDICATION; THEREFORE, WAS PRONE TO BLEEDING. A DEVICE EVALUATION IS CURRENTLY PENDING RETURN OF THE DEVICE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: CONTRAINDICATIONS: DO NOT PLACE FOAM DRESSINGS OF THE V.A.C.® THERAPY SYSTEM DIRECTLY IN CONTACT WITH EXPOSED BLOOD VESSELS, ANASTOMOTIC SITES, ORGANS, OR NERVES. WARNINGS: BLEEDING: WITH OR WITHOUT USING V.A.C.® THERAPY, CERTAIN PATIENTS ARE AT HIGH RISK OF BLEEDING COMPLICATIONS. THE FOLLOWING TYPES OF PATIENTS ARE AT INCREASED RISK OF BLEEDING, WHICH, IF UNCONTROLLED, COULD BE POTENTIALLY FATAL: PATIENTS WHO HAVE WEAKENED OR FRIABLE BLOOD VESSELS OR ORGANS IN OR AROUND THE WOUND AS A RESULT OF, BUT NOT LIMITED TO: SUTURING OF THE BLOOD VESSEL (NATIVE ANASTOMOSIS OR GRAFTS) / ORGAN INFECTION. TRAUMA. RADIATION. PATIENTS WITHOUT ADEQUATE WOUND HEMOSTASIS. · PATIENTS WHO HAVE BEEN ADMINISTERED ANTICOAGULANTS OR PLATELET AGGREGATION INHIBITORS · PATIENTS WHO DO NOT HAVE ADEQUATE TISSUE COVERAGE OVER VASCULAR STRUCTURES IF V.A.C.® THERAPY IS PRESCRIBED FOR PATIENTS WHO HAVE AN INCREASED RISK OF BLEEDING COMPLICATIONS, THEY SHOULD BE TREATED AND MONITORED IN A CARE SETTING DEEMED APPROPRIATE BY THE TREATING PHYSICIAN. IF ACTIVE BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING V.A.C.® THERAPY, OR IF FRANK (BRIGHT RED) BLOOD IS SEEN IN THE TUBING OR IN THE CANISTER, IMMEDIATELY STOP V.A.C.® THERAPY, LEAVE DRESSING IN PLACE, TAKE MEASURES TO STOP THE BLEEDING AND SEEK IMMEDIATE MEDICAL ASSISTANCE. THE V.A.C.® THERAPY UNITS AND DRESSINGS SHOULD NOT BE USED TO PREVENT, MINIMIZE OR STOP VASCULAR BLEEDING. · PROTECT VESSELS AND ORGANS: ALL EXPOSED OR SUPERFICIAL VESSELS AND ORGANS IN OR AROUND THE WOUND MUST BE COMPLETELY COVERED AND PROTECTED PRIOR TO THE ADMINISTRATION OF V.A.C.® THERAPY. ALWAYS ENSURE THAT V.A.C.® FOAM DRESSINGS DO NOT COME IN CONTACT WITH VESSELS OR ORGANS. USE A THICK LAYER OF NATURAL TISSUE SHOULD PROVIDE THE MOST EFFECTIVE PROTECTION. IF A THICK LAYER OF NATURAL TISSUE IS NOT AVAILABLE OR IS NOT SURGICALLY POSSIBLE, MULTIPLE LAYERS OF NON-ADHERENT DRESSING MATERIAL MAY BE CONSIDERED AS AN ALTERNATIVE, IF DEEMED BY THE TREATING PHYSICIAN TO PROVIDE A COMPLETE PROTECTIVE BARRIER. IF USING NON-ADHERENT MATERIALS, ENSURE THEY ARE SECURED IN A MANNER THAT WILL MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY.

    Description of Event or Problem · 1

    ON 09-AUG-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2021 THE PATIENT ALLEGEDLY PRESENTED TO THE HOSPITAL DUE TO BLOOD FILLING THE ACTIV.A.C.¿ CANISTER AND ALSO LEAKING THROUGH THE V.A.C.¿ DRESSING. THE PATIENT ALLEGED THE CAUSE OF THE BLEEDING EVENT WAS DUE TO A POPPED BLOOD VESSEL AND HAS A HEMATOMA. THE PATIENT REQUIRED A BLOOD TRANSFUSION. WHEN DISCHARGED FROM THE HOSPITAL, V.A.C.® THERAPY WAS NOT RESUMED UNTIL FURTHER EVALUATION BY THE SURGEON. ON 18-AUG-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: REVIEW OF CLINICAL NOTES DATED (B)(6) 2021 STATED THERE WERE BLOOD CLOTS IN THE PATIENT'S WOUND PRIOR TO V.A.C.® THERAPY AND WAS ON BLOOD THINNING MEDICATION. THE PATIENT DID HAVE A BLEEDING ISSUE AND WAS HOSPITALIZED. THE PATIENT WAS PLACED ON AN ALTERNATE DRESSING AND THERE WAS NO INFORMATION REGARDING THE BLOOD TRANSFUSION. THE PATIENT WAS PLACED BACK ON V.A.C.® THERAPY ON (B)(6) 2021. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEMIS PENDING RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340088 ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDARM 00849554005600

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R