|
The v.A.C.® granufoam¿ dressing type and lot number were not provided, and the product was not returned; therefore, a device evaluation and a device history record review could not be performed.Based on the information provided, it cannot be determined that the alleged infection is related to v.A.C.® granufoam¿ dressing.The wound was noted to be infected at time of placement of v.A.C.® therapy.The patient reportedly experienced a lapse in on-going wound care from appropriately trained personnel, and the same v.A.C.® granufoam¿ dressing placed on (b)(6) 2021 remained in place longer than manufacturer's recommendation.Based on the information provided, 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.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.
|
|
On 21-nov-2021, the following information was reported to kci by the patient: the v.A.C.® dressing had not been changed since placement on (b)(6) 2021.Patient unable to return to hospital where initially treated due to transportation issues and being 2 hours away.Patient reportedly presented to an urgent care clinic but would not touch the v.A.C.® dressing and advised to see clinician that applied the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Patient alleged that an odor had developed.On (b)(6) 2021, the following information was reported to kci by the patient: the patient was able to secure transportation and was planning to return to emergency department for wound evaluation.The same v.A.C.® dressing remained in place.The patient reported redness to area surrounding wound and odor but no increased pain or swelling noted.On 09-dec-2021, the following information was reported to kci by the patient: the patient allegedly presented to an emergency department.Patient was given antibiotics and referred to a local wound care center, but the dressing was not removed and same v.A.C.® dressing from (b)(6) 2021 was still in place.Patient was told the wound care center did not do v.A.C.® therapy dressing changes.On 09-dec-2021, the following information was reported to kci by the assistant nurse manager of the emergency department: on (b)(6) 2021 the patient presented to the emergency department.The nurse stated that the doctor prescribed antibiotics and gave the patient a referral for the wound care center.There were notes confirming that v.A.C.® dressing was in place at time of visit and no notes confirming dressing was removed to assess wound.The nurse stated they do not carry v.A.C.® therapy supplies and therefore dressing could not be replaced.The doctor did not submit orders for a change to the dressing or treatment; therefore, the v.A.C.® dressing was left in place and an alternate dressing was not placed.The v.A.C.® granufoam¿ dressing type and lot number were not provided, and the product was not returned; therefore, a device evaluation and a device history record review could not be performed.
|
