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On (b)(6) 2022, the following information was reported to kci by the patient's family member: on (b)(6) 2022, the patient was readmitted to the hospital allegedly "due to odor, infection, and now 2 inches of bone exposed".The patient allegedly experienced a technical issue with the activ.A.C.¿ ion progress¿ remote therapy monitoring system prior to the event as the device was "in place and not working with no alarms going off to indicate it." the patient was started on antibiotics.On (b)(6) 2022, the following information was reported to kci by the nurse: the patient was hospitalized due to a seizure, and she was unaware of any issues that may have occurred with v.A.C.® therapy.On (b)(6) 2022, the following information was reported to kci by the nurse: the patient was not admitted to one of the hospitals that they are affiliated with and it was difficult to get information until patient is discharged.The nurse did state that patient's admission to the hospital was unrelated to v.A.C.® therapy.The patient has several underlying health issues which were the cause of admission.V.A.C.® therapy is currently on hold.On 04-may-2022, the following information was reported to kci by the patient's family member: the patient was admitted to the hospital for reasons unrelated to v.A.C.® therapy on 20-apr-2022.Upon removal of the v.A.C.® dressing on 21-apr-2022, the wound was found to be necrotic, infected, and larger.Healthcare providers suspect a bone infection, and the patient is currently being treated with antibiotics while they remain inpatient.V.A.C.® dressing had last been changed the monday evening prior to admission.When v.A.C.® therapy was removed on 21-apr-2022, it was identified that the unit appeared to be on and working but was not functioning correctly.When seal was broken during removal, the unit also did not alarm.The v.A.C.® dressing was being changed every monday, wednesday, and friday evening and sometimes more often if there were any issues with leaks as wound location was in a difficult anatomical location.Per review of kci records: on (b)(6) 2022, the wound was not assessed by the home health nurse as the caregiver had completed wound care.No additional information available.On (b)(6) 2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks 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 a 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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Based on the information provided, it cannot be determined that the alleged odor, infection, necrosis and bone exposure are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.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.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.
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