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Date of event: the exact date of the event is unknown, therefore (b)(6) 2021, was utilized.Based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient had a lengthy complicated hospital course and underwent multiple surgical procedures prior to placement of the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient reportedly experienced technical issues with the device and left the v.A.C.® dressing in place over the manufacturers' recommendation.A device evaluation is currently pending device return.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.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.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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On 18-oct-2021, the following information was reported to kci by the patient: on (b)(6) 2021, the patient experienced technical issues with the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient was admitted to the hospital allegedly due to developing a fever and cellulitis to the surrounding skin and was currently inpatient receiving intravenous antibiotics.On 03-nov-2021, the following information was reported to kci by the nurse: the patient was admitted for a wound infection and the patient reported technical issues with the device.The patient tried to contact the home health nurse, but was unsuccessful, thus, presented to the emergency room for assistance.The patient was admitted at that time and treated with antibiotics before being discharged to a skilled nursing facility on (b)(6)2021.On 03-nov-2021, the following information was reported to kci by the patient: on (b)(6) 2021, the patient was admitted for a left groin wound infection and was treated with intravenous antibiotics followed by oral antibiotics.On (b)(6) 2021, the patient was discharged home and v.A.C.® therapy resumed.On 11-nov-2021, the following information was reported to kci by the patient: on (b)(6) 2021, the patient called emergency medical services for technical assistance with the activ.A.C.¿ ion progress¿ remote therapy monitoring system and was supplied with extra non-kci products to help reinforce the v.A.C.® dressing.The technical issues persisted despite the patient's family member's attempts to resolve them.The patient went to sleep and the v.A.C.® dressing was left in place without active therapy.The patient "woke up sweaty with a fever, chills, and body aches" and was admitted to the hospital for cellulitis.On (b)(6) 2021, the patient was discharged home due to the infection improving.On (b)(6) 2021, the patient experienced technical issues with the device which caused the "dressing to back up".The patient left the v.A.C.® dressing in place without active v.A.C.® therapy again and was readmitted for worsening infection that had spread from the left groin to the left hip.The patient underwent surgery to clean out the wound, received intravenous and oral antibiotics, and was discharged home on (b)(6) 2021.V.A.C.® therapy resumed upon discharge and patient reported no further issues to date.The patient is not currently on antibiotics and the wound is healing well.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending return of the device.Refer to mdr 3009897021-2021-00262 for the alleged events that occurred on (b)(6) 2021.
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On 09-dec-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 service center, 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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