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Based on the information provided, it cannot be determined that the alleged slough to the right ankle wounds and abscess above the wounds, requiring surgery, were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The physician reported that a continuation from the open wounds to the new abscess was suspected but not found.The patient has a history of a dehisced wound following surgery for a traumatic injury to her right ankle.The patient also required additional surgery six weeks post initial injury and prior to v.A.C.® therapy placement due to wound deterioration and infection.The device passed quality control checks and met specifications before and after placement with the patient.The physician reported the patient was not charging the device properly, was non-compliant with elevating her leg, as well as other "social issues" that could have contributed.Therefore, this event is being reported due to potential use error.Device labeling, available in print and online, states: warning: 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 alternate dressing, such as a wet to moist gauze, as approved during times of extreme need, by treating physician.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.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.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.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.
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On (b)(6) 2022, the following information was provided to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly did not hold a charge and was powering off, and was not alarming.On (b)(6) 2022, the following information was provided to kci by the physician: the activ.A.C.¿ ion progress¿ remote therapy monitoring system was allegedly not working correctly, not alarming, and caused major injuries requiring the patient to return to the hospital for additional surgery.On (b)(6) 2022, the following information was provided to kci by the physician: the patient was seen on (b)(6) 2022 and had gross lymphedema to the right lower extremity, up to the knee, as well as slough to the lateral and medial right ankle wounds.The patient also had developed an abscess above the wounds and even though the physician could not find a continuation from the wounds to the abscess, the physician suspects there is a continuation.The patient required surgical irrigation and debridement as well as drainage of the new abscess.The physician stated that she witnessed, on more than one occasion, the patient coming into the office with the activ.A.C.¿ ion progress¿ remote therapy monitoring system powered on; however, there was fluid leaking from the drape, and the device was not alarming.The physician also stated that she believes there were other issues that contributed including failure of the patient to follow instructions; the patient was not charging the unit properly, as evidenced by multiple battery low/critical alarms recorded in the device event logs, possibly leading to inactive v.A.C.® therapy as well as the device powering off.The patient also has not been elevating her leg as prescribed and other social issues may have contributed.The patient reported to the physician that the home health nursing staff struggled with the dressing changes and did not apply the dressings properly.On (b)(6) 2022, a device evaluation was completed by kci quality engineering.On (b)(6) 2022, the device was tested per quality control procedure by kci service center, and the device passed and met specifications.On (b)(6) 2022, the device was placed with the patient.On (b)(6) 2022, the device was tested per quality control procedure by kci service center and the device passed 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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