BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C.® THERAPY

    MDR report key: 6063761 · Received October 28, 2016

    Report

    Report Number
    3009897021-2016-00093
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 5, 2016
    Manufacturer
    KCI USA,INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MDR-3009897021-2016-00093 (B)(4) INVESTIGATES THE BLEEDING EVENT THAT OCCURRED ON (B)(6) 2016 AS THIS HEMORRHAGE RESOLVED WITHOUT MEDICAL OR SURGICAL INTERVENTION, BUT THE PATIENT WAS TAKEN FOR AN EMERGENCY THORACOTOMY TO LOCATE THE SOURCE OF THE BLEEDING, AND NO OBVIOUS DAMAGE WAS FOUND. MDR-3009897021-2016-00092 (B)(4) INVESTIGATES THE BLEEDING EVENT THAT OCCURRED ON (B)(6) 2016 AS IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO RESOLVE THE HEMORRHAGE. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED HEMORRHAGE THAT OCCURRED ON (B)(6) 2016 WHICH THE PATIENT UNDERWENT A THORACOTOMY IS RELATED TO V.A.C THERAPY. THE HEMORRHAGE RESOLVED ON ITS OWN WITH NO MEDICAL OR SURGICAL INTERVENTION, BUT THE PATIENT WAS TAKEN FOR AN EMERGENCY THORACOTOMY TO LOCATE THE SOURCE OF THE BLEEDING, AND NO OBVIOUS DAMAGE WAS FOUND. THE PHYSICIAN REPORTED THAT "WE CONSIDER THIS EVENT WAS THE SUBCUTANEOUS HEMORRHAGE FROM THE WOUND, SINCE THE HEART AND THE GREAT VESSELS WERE NOT DAMAGED AND THE BLEEDING LESIONS WERE NOT FOUND WHEN THE BREAST WAS OPENED TO IDENTIFY THE LOCATION OF BLEEDING. THIS PATIENT WAS ON DIALYSIS TREATMENT, AND SOMETIMES THE VENOUS PRESSURE BECOMES HIGHER DUE TO THE SHUNT ON THE UPPER EXTREMITY." DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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. : NO DEVICE IDENTIFIER PROVIDED.

    Additional Manufacturer Narrative · 1

    BASED ON THE ADDITIONAL INFORMATION OBTAINED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED HEMORRHAGE REQUIRING A THORACOTOMY IS RELATED TO V.A.C. THERAPY.

    Description of Event or Problem · 1

    ON OCT 05 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI (B)(4) BY THE PHYSICIAN: THE ACTIV.A.C.UNIT WAS USED FOR A PATIENT WITH CHRONIC RENAL FAILURE RECEIVING HEMODIALYSIS. THE PATIENT HAD THE SHUNT ON THE LEFT UPPER EXTREMITY. ON (B)(6) 2016, THE PATIENT UNDERWENT AN EMERGENCY OPERATION TO REPLACE THE ASCENDING AND ARCH OF THE AORTA DUE TO AN AORTIC DISSECTION. ON (B)(6) 2016, THE POSTOPERATIVE OPEN WOUND WAS 2.5CM IN LENGTH AND 2CM IN DEPTH WITH EXPOSED FASCIA APPROXIMATELY 0.5 CM UNDER THE LEFT CLAVICLE. LAVAGE TREATMENT WAS STARTED. ON (B)(6) 2016, THE WOUND WAS WASHED AND V.A.C. THERAPY TREATMENT STARTED AT -125 MMHG. ON (B)(6) 2016, THE V.A.C GRANUFOAM DRESSING AND DRAPE WERE REPLACED. NO BLEEDING WAS OBSERVED AND V.A.C. THERAPY TREATMENT CONTINUED. IN THE EARLY MORNING OF (B)(6) 2016, "MASSIVE" BLEEDING WAS OBSERVED AT THE WOUND, AND THE PATIENT'S BLOOD PRESSURE DECREASED. V.A.C. THERAPY TREATMENT WAS INTERRUPTED. AFTER INTERRUPTION, THE BLEEDING RESOLVED ON ITS OWN. AS THE REASON FOR BLEEDING WAS UNKNOWN, THE PATIENT UNDERWENT AN EMERGENCY THORACOTOMY. THE WIRES RETAINED TO THE BREAST BONE WERE REMOVED IN ORDER TO OBSERVE THE HEART AND BLOOD VESSELS, BUT NO OBVIOUS DAMAGE WAS FOUND. A J-V.A.C. DRAIN [A NON-KCI PRODUCT] WAS RETAINED AND THE BREAST WAS CLOSED." V.A.C. THERAPY WAS RESUMED. IN THE EARLY MORNING OF (B)(6) 2016, BLEEDING WAS OBSERVED FROM THE INSERTION PART OF THE PATIENT'S J-VAC DRAIN [A NON KCI PRODUCT], AND THE PATIENT'S BLOOD PRESSURE DECREASED. AN EMERGENCY THORACOTOMY WAS CONDUCTED TO LOCATE THE SOURCE OF THE BLEEDING. THE PATIENT'S AORTA, PERICARDIAL SACS AND THE PERIPHERALS WERE CHECKED FOR A HEMATOMA, BUT NO HEMATOMA WAS FOUND. THE INFLUENCE OF THE INCREASE IN THE VENOUS PRESSURE CAUSED BY THE SHUNT ON THE UPPER EXTREMITY WAS SUSPECTED, AND THE SHUNT WAS OBSTRUCTED. ON (B)(6) 2016, NO BLEEDING WAS OBSERVED, AND THE PATIENT'S WOUND WAS CLOSED." THE PATIENT'S VITAL SIGNS INCLUDING VENOUS PRESSURE, BLOOD PRESSURE, BLOOD DATA INCLUDING PLATELET COUNT AT THE TIME OF THE BLEEDING WAS NOT AVAILABLE. SINCE THE UNIT'S SERIAL NUMBER WAS NOT PROVIDED, KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Description of Event or Problem · 1

    ON AUG 16 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI (B)(4) SERVICE CENTER, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON OCT 11 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI (B)(4) SERVICE CENTER, AND THE 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
    716699 ACTIV.A.C.® THERAPY OMP OMP KCI USA,INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention