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Based on information provided, it cannot be determined that the alleged maceration and subsequent graft failure are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending completion.Device labeling, available in print and online, states: precautions : protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile / friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.-multiple layers of v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration.Foot wounds: foot wounds for wounds on the plantar surface or heel of the foot, it is best to use a bridging technique to ensure that additional pressure is not applied as a consequence of placement of the tubing and/or sensat.R.A.C.¿/t.R.A.C.¿ pad.This involves using the foam to allow placement of the sensat.R.A.C.¿/t.R.A.C.¿ pad or tubing on the dorsum of the foot (consider use of the v.A.C.® granufoam¿ heel dressing).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.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.If the wound is over a bony prominence or in an area where weight bearing may exert additional pressure or stress to the underlying tissues, a pressure-relief surface or device should be used to optimize patient off-loading.Always count the total number of pieces of foam used in the wound.Document the foam quantity and dressing change date on the drape of foam quantity label if available, and in the patient's chart.Changes in wound color: if the wound appears white, excessively moist or macerated: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours.Find out why there is a therapy deficit and remedy the situation.The exudate volume should experience a gradual decrease as the extracellular debris is brought to equilibrium.Persistent large volumes of exudate may signal an infection or other complications and should be evaluated by the prescribing clinician.Determined in occult infection is present.Increase pressure settings by 25 mmhg increments if drainage increases.Determine if there is a positional seal leak, which may be preventing effective exudate removal.Evaluate dressing technique.Assess for the need to bridge sensat.R.A.C¿ pad away from the wound.Protect the surrounding tissue with v.A.C.® drape or a hydrocolloid.Isolate wound drainage from periwound skin.Determine inf patient is adequately off-loading or if there is a potential for external pressure on the wound / dressing, which may cause the wound exudate to be forced onto the periwound skin.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.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.Initial application and dressing changes: grafts: v.A.C.® therapy may not be suitable for placement over some products that create a barrier to fluid removal.Check with the product's manufacturer prior to use with v.A.C.® therapy.Apply v.A.C.® dressing immediately after graft placement and begin therapy as soon as possible.When using v.A.C.® granufoam¿ dressings, a non-adherent dressing should be placed directly over the graft/tissue.In general, the pressure setting used to prepare the recipient bed before grafting should be continued after grafting.Continuous therapy should be used to provide a constant bolster.
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On (b)(6) 2021, the following information was provided to kci by the patient: on (b)(6)2021, the patient allegedly experienced a leak and the activ.A.C.¿ ion progress¿ remote therapy monitoring system made continuous noise.The patient's wound reportedly dried out and drained onto the skin on the top of the foot which is now macerated.The patient attempted to contact kci multiple times but was reportedly unsuccessful in speaking to technical support to troubleshoot the issue.The wound care removed v.A.C.® therapy to allow the patient's skin to heal and dry out.On (b)(6) 2021, kci received and reviewed two images provided by the patient: the first image exhibited a wound located on the top of the left foot covered with a film.A brownish discoloration is noted in the center of the wound.The second image exhibited a left foot with a dressing applied to the foot.The round interface pad in partly on top of a black foreign material and the patient's skin.There is brownish red drainage located underneath the film on the left lateral and superior aspect of the foot.On (b)(6) 2021, the following information was provided to kci by the nurse practitioner: the had a biological graft placed in the operating and vac therapy as initiated.On (b)(6)2021, the patient was seen and confirmed the patient's graft failed requiring a debridement to remove the graft.V.A.C.® therapy was reapplied.The patient is now being seen 3 times weekly for dressing changes.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending completion.
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On (b)(6) 2021, a device evaluation was completed.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.On (b)(6) 2021, the device was tested per quality control procedure by kci quality engineering 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.
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