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On 29-jun-2026, the following information was received by the patient: the patient reported the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring alarmed "canister full" when the canister was not full and stopped therapy without alarming.The graft allegedly failed due to the malfunction.On 13-jul-2026, the following information was received via fax by the physician: the physician indicated the reported graft failure was caused or contributed to by the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring.A lack of suction from the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring resulted in the skin graft not adhering properly to the underlying wound bed, contributing to the graft failure.The activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring malfunctioned by failing to maintain adequate suction throughout the entire battery life of the unit.The provider confirmed that the v.A.C.® dressing type in use at the time of the alleged event was the v.A.C.® granufoam¿ dressing; however, the v.A.C.® dressing lot number was unknown.The patient will require an additional procedure to place another skin graft to cover the defect.Despite the reported graft failure, the wound is improving and that v.A.C.® therapy continued following receipt of a replacement v.A.C.® therapy unit.¿
a device evaluation of the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring is pending completion.
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Based on the information provided, it cannot be determined that the alleged graft failure is related to the activ.A.C.¿ therapy system with ion progress¿ remote therapy monitoring.A device evaluation is pending completion.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.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.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.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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