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Based on the information provided, it could not be determined that the alleged skin graft partially taking and moisture/maceration affecting the periwound requiring debridement were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after 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.Foot wounds for wounds on the plantar surface or heel of the foot, it is best to use a bridging technique to ensure that additional pressure is not applied as a consequence of the placement of the tubing and / or sensat.R.A.C.¿ pad.This involves using foam to allow placement of the sensat.R.A.C.¿ pad or tubing on the dorsum of the foot.Appropriate off-loading of the foot is essential in order to maximize the therapeutic benefit of v.A.C.® therapy.Deterioration of the wound 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: if available on the therapy unit, check the therapy history log to ensure 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.
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On 25-jun-2021, the following information was reported to kci by the wound care center nurse: on (b)(6) 2021, the patient was seen, and the nurse practitioner progress note states that the split thickness skin graft does not appear to have taken well allegedly due to technical issues with the activ.A.C.¿ ion progress¿ remote therapy monitoring system.On 25-jun-2021, the following information was received by kci after a review of the progress note dated (b)(6) 2021: patient was in the emergency department two times last weekend with v.A.C.® malfunction.The patient called the product 1-800 number and troubleshooted unsuccessfully (machine was reading out "blockage").Says the machine never gave the indication that the suction stopped, but would alarm and pressure read 25-50 mmhg.Periwound assessment states fragile and maceration.V.A.C.® therapy was discontinued.On 09-jul-2021, the following information was received by kci after a review of the surgeon's progress note dated (b)(6) 2021: in the first couple of days following this procedure the v.A.C.® failed at least twice requiring patient to present to emergency room.The v.A.C.® was reportedly salvaged and continued.V.A.C.® was taken off at wound care center on (b)(6) 2021.Skin: wound of left foot at hallux amputation site, 4 cm x 3 cm.There is 50 to 60% take of the skin graft, and other areas it does appear somewhat dusky and macerated.There is granulation tissue on other portions of the wound.I would like to give this time and see ultimately how the wound heals.On 09-jul-2021, the following information was received by kci after a review of the nurse practitioner progress note dated (b)(6) 2021: periwound assessment: intact.Wound length 2 cm; wound width 3 cm; wound depth 0.1 cm.Procedure: skin graft site debrided of non-viable dermis and slough using a sterile curette.This was a non-excisional debridement.Severity of wound: now open skin layer.On 09-jul-2021, the following information was received by kci after a review of the nurse practitioner progress note dated (b)(6) 2021: periwound assessment: intact.Wound length 2 cm; wound width 2.5 cm; wound depth 0.1 cm.Procedure: skin graft site debrided of non-viable dermis and slough using a sterile curette.This was a non-excisional debridement.Severity of wound: now open skin layer - improved.Split thickness skin graft - 80% take.On 27-may-2021, the device was tested per quality control procedure by a kci service center, and the device passed and met specification.On (b)(6) 2021, the device was placed with the patient.The device was returned to kci on 06-jul-2021, tested per quality control procedure by kci quality engineering and passed.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.
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