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Based on information provided, it cannot be determined that the alleged wound discoloration is related to the activ.A.C.¿ therapy system.The nurse practitioner could not confirm if the discoloration was related to v.A.C.® therapy or just progression of the wound.It is unknown if either the discoloration was necrotic tissue or if the patient had a confirmed infection.Thus, it cannot be determined that the sharp debridement was performed for the discoloration or the possible signs of an infection.Activ.A.C.¿ therapy system was placed on (b)(6) 2018 and seven days later on (b)(6) 2018, the nurse practitioner noted the patient was placed on antibiotic therapy ¿last week.¿ there have been several attempts made to gather additional information, but there has been no response.The patient has a known history of e.Coli wound infection, and prior attempts were made to culture the wound indicating signs of an infection were previously observed.Device labeling, available in print and online, states: 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.Device labeling, available in print and online, states: 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 and instillation therapy parameters (for the v.A.C.Instill® therapy system).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) 2018, the following information was reported to kci by the nurse practitioner: the dressing allegedly stained the inside of the patient¿s wound black.On jan 24 2018, the following information was reported to kci by the nurse practitioner: the patient was placed on activ.A.C.¿ therapy system on (b)(6) 2018, and on (b)(6) 2018, the home care nurse noted there were small areas of ¿blackening in the wound bed".On (b)(6) 2018, the home care nurse observed the patient¿s wound and alleged the patient¿s wound bed was completely blackened.On (b)(6) 2018, the nurse practitioner observed the wound and noted a foul odor.The nurse practitioner stated she had previously placed the patient on a broad spectrum antibiotic regimen "last week".The nurse practitioner confirmed there is no v.A.C.® granufoam¿ dressing in the patient¿s wound.The nurse practitioner attempted to sharp debride the patient¿s wound, but the patient was unable to tolerate the procedure.A plan was made to subsequently perform a sharp debridement in the operating room and obtain biopsies with wound cultures.The nurse practitioner noted that previous cultures had not been confirmed due to the inability to obtain a sample large enough to perform a culture.On jan 30 2018, the following information was reported to kci by the nurse practitioner: the patient underwent sharp debridement in the operating room on (b)(6) 2018.The nurse could not confirm if the alleged discoloration was related to activ.A.C.¿ therapy system or just progression of the wound.On (b)(6) 2018, the patient was seen in clinic and the wound was ¿much improved¿.On dec 14 2017, the device passed quality control checks and met specifications before placement with the patient.On (b)(6) 2018, the device was placed with the patient.On feb 05 2018, the device was tested per quality control procedure by kci quality engineering.The testing was performed on the device utilizing a v.A.C.® dressing on a test board.The unit was run overnight in continuous therapy mode set at 125 mmhg.The device functioned properly, maintained pressure and obtained an appropriate dressing seal.There were no alarm conditions or operational malfunctions experienced during this run on the test board.The v.A.C.® granufoam¿ dressings lot number is not available, therefore a device history review could not be performed.
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