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On (b)(6) 2021, the following information was reported to kci by the patient: approximately five weeks ago, the patient stopped using the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly due to a worsening odor coming from the patient's foot wound.The patient's home health nurse stopped coming out, and the prescribing provider was getting back to the patient.The patient switched to an alternate dressing and seemed to be improving.On (b)(6) 2021, the following information was reported to kci by the nurse: the patient was discharged as of (b)(6) 2021 and the patient had several missed visits prior to that.There was no information noted regarding the wound deteriorating or an abnormal odor.On (b)(6) 2021, the following information was reported to kci by the patient: for a period of 4-5 weeks, the patient was performing their own wound care "sometime in august to september" as the home health nurse only showed up for two visits and it "took weeks for [patient's] physician to write a new order for home health." the patient changed the v.A.C.® dressing on their own, however it was difficult due to the location of the wound.During that time, the wound worsened, and the patient sought treatment at the emergency department.The patient attributed the wound deteriorating to the "neglect and negligence" of their physician.On (b)(6) 2021, the following information was reported to kci by the home health nurse: the patient was last seen on (b)(6) 2021 due to an issue with insurance authorization for services.The nurse was not sure if the patient continued using the device after being discharged from services.On (b)(6) 2021, medical records provided by the healthcare provider were received by kci which noted the following: on (b)(6) 2021, the patient presented for a follow up wound assessment and it was noted that the wound had "gotten much worse" and was "very foul smelling." the patient reported that they had been performing their own wound care and verbalized understanding that the wound would require further surgery, but refused to go to the hospital at that time as there was no pain secondary to neuropathy.The patient requested to be admitted between halloween and thanksgiving.The physician stated that was not acceptable, and the patient agreed to come back to the clinic the following week for a re-evaluation and further discussion about possible surgical intervention.Bactrim and keflex were prescribed and v.A.C.® therapy was reapplied.On (b)(6) 2021, the patient presented to their primary care physician for an unrelated medical issue.It was noted that v.A.C.® therapy was no longer in use.On (b)(6) 2021, the patient presented for follow-up with their prescribing physician.At this time, a new referral was written for home health to perform v.A.C.® dressing changes.The physician counseled the patient on the importance of compliance with medical treatment and disease management.The physician advised that surgical intervention would not be of benefit if the patient was non-compliant and a poor outcome would ultimately be the result as the patient would lose their leg.No further information provided.A device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending return of the device.
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Based on the information provided, it cannot be determined that the alleged wound deterioration and infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The worsening odor alleged on (b)(6) 2021 was determined not to meet the definition of a serious injury as the nurse reported that there was no documentation of an odor or wound deterioration at that time, and the patient reported the odor improved without allegation of harm or injury.The initial wound type was a surgical debridement and osteotomy of the fifth metatarsal due to osteomyelitis.The osteomyelitis had progressed despite amputation of the first metatarsal, one round of intravenous antibiotics, and one round of oral antibiotics.Additionally, the physician noted that the patient's condition was guarded at the time the device was placed intraoperatively.The patient reportedly experienced a lapse in on-going wound care from appropriately trained personnel and began performing their own dressing changes against the manufacturers' recommendation.A device evaluation is currently pending device return.Based on the additional information provided on (b)(6) 2021, this event is being reported due to potential use error.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.Transition patients between care settings: if the post-acute v.A.C.® therapy unit is not available or discharge, and therapy will be off for more than two hours, remove the v.A.C.® therapy dressings before the patient is discharged.Apply an alternative dressing, such as wet to moist gauze, as approved during times of extreme need, until the new v.A.C.® therapy unit is delivered, and appropriately trained personnel are prepared to provide on-going care of the patient.V.A.C.® therapy should not be discharged with a patient if the clinician has a question about the availability of appropriately trained personnel.V.A.C.® therapy dressings should be removed and an appropriate alternative dressing applied until trained personnel are secured by the healthcare provider and a v.A.C.® therapy unit is delivered.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.Osteomyelitis: v.A.C.® therapy should not be initiated on a wound with untreated osteomyelitis.Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected bone (if necessary), and appropriate antibiotic therapy.Protect intact bone with a single layer of non-adherent material.Wound infection: call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever.Your wound is sore, red or swollen.Your skin itches or you have a rash or redness around the wound.The area around the wound feels very warm.You have pus or a bad smell coming from the wound.Infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected 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.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.
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