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The device was discarded; therefore, a device evaluation could not be performed.Based on information provided, kci could not determine that the alleged bleeding and infection are related to the v.A.C.® drape.The nurse reported the bleeding was secondary to the infection and complicated by the pre-existing fistula.The patient had ongoing issues maintaining the seal of a colostomy bag which led to the wound getting worse.The patient had an extensive medical and surgical history related to ongoing abdominal issues and a coloenteric fistula with ongoing mesh infection issues prior to initiation of v.A.C.® therapy.Furthermore, the nurse reported the patient was doing significantly better while on v.A.C.® therapy.A device history record review for the device met specifications.Kci is reporting this event as the nurse reported that the v.A.C.® drape seal may have been compromised.Device labeling, available in print and online, states: 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 if not: make sure the display screen reads therapy on.If not, press the therapy on/off button.Confirm the clamps are open and the tubing is not kinked.Identify air leaks by listening with a stethoscope or moving your hand around the edges of the dressing while applying light pressure.If you find that the seal is broken and the v.A.C.® drape has become loose, trim away any loose or moist edges, ensure the skin is dry and then apply new drape strips.Note: if a leak source is identified, patch with additional drape to ensure seal integrity.Caution: use as few layers of drape as possible.Multiple layers of the v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration, especially in small wounds, lower extremities or load-bearing areas.Maintaining a seal: maintaining a seal around the dressing is key to successful v.A.C.® therapy.Recommendation to maintain the integrity of the seal: dry the periwound thoroughly after cleansing.A protective skin barrier preparation may be used to prepare the skin for drape application (e.G.A liquid barrier film or surgical adhesive).For delicate periwound tissue or in areas that are difficult to dress, apply protective skin preparation and frame the wound with transparent film or a hydrocolloid dressing or other appropriate barrier.Ensure v.A.C.® granufoam¿ dressing is appropriate for the depth of the wound by either cutting or beveling it, or use specific thinner v.A.C.® granufoam¿ dressings where indicated.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.
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On (b)(6) 2021, the following information was reported to kci by the patient: on (b)(6) 2021, the patient reported difficulty in maintaining a seal with the v.A.C.® drape due to the shallow depth of the wound.The nurse reported that the seal issue resolved with cutting the v.A.C.® granufoam¿ dressing in half.The nurse obtained a wound culture at that time allegedly due to blood noted in the drainage.On (b)(6) 2021, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold allegedly due to a wound infection and the patient was started on antibiotics.The wound would be reassessed the following week and a determination to resume or discontinue v.A.C.® therapy would be made at that time.On (b)(6) 2021, the following information was reported to kci by the physician's nurse: on (b)(6) 2021, wound culture results obtained (b)(6) 2021 confirmed a wound infection and, to date, v.A.C.® therapy has not resumed.The patient has a colostomy bag due to a pre-existing coloenteric fistula, for which maintaining a seal with the colostomy bag has led to a deterioration in the wound from bowel leakage.Due to this and the close proximity of the wound to the colostomy site, the v.A.C.® drape seal may have potentially been compromised.The patient was doing significantly better while utilizing v.A.C.® therapy.Since v.A.C.® therapy has been removed, the wound has declined as there is no barrier in place to prevent cross contamination.On (b)(6) 2021, the following information was reported to kci by the home health nurse: v.A.C.® therapy did not cause or contribute to the alleged infection.The pre-existing fistula caused feces to leak into the wound which led to an infection and current hospitalization.All complications to date were reported unrelated to v.A.C.® therapy.On (b)(6) 2021, the following information was reported to kci by the clinical nurse director: the alleged bloody drainage was considered minor and secondary to wound infection complicated by a pre-existing coloenteric fistula.The patient was placed on an alternate dressing and antibiotic therapy to resolve the issue.No additional clinical information was available.On (b)(6) 2021, a device history record review for the v.A.C.® granufoam¿ dressing lot number 8993890v009 was completed.All end release testing of product and packaging met specifications.
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