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Date of event: the initial date of infection could not be determined; therefore, the date the infusion nurse indicated "the entire room was smelling", (b)(6) 2022, was utilized.The v.A.C.® granufoam¿ dressing was not returned; therefore, a device evaluation could not be performed.Based on information provided, it cannot be determined if the alleged infection secondary to the embedded foreign material is related to the v.A.C.® granufoam¿ dressing as the patient had a pre-existing wound infection.The initial wound type was a surgical debridement of bilateral lower venous stasis ulcers complicated by infection with recent placement of v.A.C.® therapy on (b)(6) 2022.Additionally, it cannot be determined when the foreign material alleged to be v.A.C.® granufoam¿ dressing was placed in the wound.The foreign material was not returned to kci for identification; therefore, kci is unable to confirm its identity.The foreign material was allegedly left in the wound for over the manufacturer's recommendations.Based on the additional information provided via medical records on 16-aug-2022, 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.Foam placement: always use v.A.C.® dressings from sterile packages that have not been opened or damaged.Do not place any foam dressing into blind / unexplored tunnels.The v.A.C.® whitefoam¿ dressing may be more appropriate for use with explored tunnels.Do not force foam dressings into any area of the wound, as this may damage tissue, alter the delivery of negative pressure or hinder exudate and foam removal.Always count the total number of pieces of foam used in the wound.Document the foam quantity and dressing change date on the drape or foam quantity label if available, and in the patient's chart.Foam removal: v.A.C.® foam dressings are not bioabsorbable.Always count the total number of pieces of foam removed from the wound and ensure the same number of foam pieces are removed as were placed.Foam left in the wound for greater that the recommended time period may foster ingrowth of tissue into the foam, create difficulty in removing the foam from the wound or lead to infection or other adverse events.If dressing adheres to wound consider introducing sterile water or normal saline into the dressing, waiting 15 - 30 minutes, then gently removing the dressing from the wound.Regardless of treatment modality, disruption of the new granulation tissue during any dressing change may result in bleeding at the wound site.Minor bleeding may be observed and considered expected.However, patients with increased risk of bleeding, as described on page 8, have a potential for more serious bleeding from the wound site.As a precautionary step, consider using v.A.C.Whitefoam¿ dressings or nonadherent material underneath the v.A.C.® granufoam¿ dressings to help minimize the potential for bleeding at dressing removal in these patients.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.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 reported to kci by the patient: the patient allegedly experienced pain and noted a foul wound odor.The patient was awaiting supplies and an exchange of the activ.A.C.¿ ion progress¿ remote therapy monitoring system after reporting a technical issue with the device on (b)(6) 2022.The patient was unable to troubleshoot the issue on (b)(6) 2022 and powered off the unit, leaving the v.A.C.® granufoam¿ dressings in place without active therapy for two days.The patient reported the nurse practitioner had just left and advised the patient that "everything looked okay except for the patient's pulse being at 123." the patient was advised to seek medical attention for further evaluation and indicated they had an appointment scheduled with their healthcare provider in three days.The patient was again advised to seek medical assistance if the home health or healthcare provider could not see the patient that day as the wounds should be assessed to ensure there was no infection present.The patient stated that they "just left the hospital" and did "not want to go back to er." the patient was provided information regarding the manufacturers' recommendation on not leaving the dressings in place for more than two hours without active therapy due to infection risk.On 08-aug-2022, the following information was reported to kci by the nurse: on (b)(6) 2022, the nurse saw the patient and performed infusion care as ordered."the entire room was smelling so [the nurse] just put gauze around wound" and "will get with [the nurse's] office to help patient".On 16-aug-2022, medical records were provided to and reviewed by kci which noted the following: on (b)(6) 2022, the patient was seen by their physician and referred to the emergency room for removal of an embedded foreign material to bilateral lower extremity wounds, alleged to be v.A.C.® granufoam¿ dressings.The home health nurse did not change the dressings as ordered, and they were left in place for several days without active therapy.On (b)(6) 2022, the patient was admitted for a wound infection and surgical excision of the v.A.C.® granufoam¿ dressings.The healthcare provider's "assessment/plan" noted "elderly female with multiple medical problems, chronic nonhealing ulcers involving bilateral lower extremities status post previous surgical debridement, admitted with fever, leukocytosis, lactic acidosis, embedded lower extremities wound dressing/packing.No evidence of other source of infection at this time.Plans for wound debridement at the or by vascular surgery.Ivf (intravenous fluids) per sepsis protocol." the patient was started on intravenous antibiotics and transferred to the intensive care unit.On (b)(6) 2022, the patient underwent surgical debridement and excision of the embedded v.A.C.® granufoam¿ dressings.Hemostasis was achieved with manual pressure and the patient resumed v.A.C.® therapy while inpatient.On (b)(6) 2022, the patient discharged home with a new activ.A.C.¿ ion progress¿ remote therapy monitoring system in place.No additional information provided.The v.A.C.® granufoam¿ dressing was not returned; therefore, a device evaluation could not be performed.On 08-sep-2022, a device history record review for the v.A.C.® granufoam¿ dressing lot number a02037v009 was completed.All end release testing of product and packaging met specifications.
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