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On 27-jun-2022, the following information was provided to kci by the patient's family member: the patient's wound allegedly began to bleed when the nurse was cleaning the wound.The nurse instructed the patient to go to the emergency room.On 14-jun-2022, the following information was provided to kci by the nurse: during the dressing change on (b)(6) 2022, manual removal of adhered foreign material alleged to be v.A.C.® dressing reportedly caused patient's wound to bleed.The nurse applied a pressure dressing for 20 minutes in an attempt to control the bleeding but was unsuccessful.The nurse advised patient be evaluated in the emergency room for further medical treatment.The patient went to the emergency room.On 15-jul-2022, the following information was provided to kci by the nurse: the patient was scheduled to have wound care three times per week.During the week of (b)(6) 2022, the patient refused visits on monday and wednesday and by the visit on friday, (b)(6) 2022, the v.A.C.® granufoam¿ dressing had allegedly embedded into the wound.Upon removal, the bleeding occurred.On 15-jul-2022, the following information was provided to kci by the nurse: clinical records dated (b)(6) 2022 were submitted indicating the patient was admitted to the hospital on (b)(6) 2022 and underwent surgical debridement on (b)(6) 2022.After the debridement, the bleeding significantly improved.The v.A.C.® granufoam¿ dressing lot number was not provided and was not returned, therefore a device history record review and device evaluation could not be completed.
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The v.A.C.® granufoam¿ dressing lot number was not provided and not returned; therefore, a device history record review and a device evaluation could not be performed.Based on information provided, it cannot be determined when the adhered 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.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.Bleeding: with or without using v.A.C.® therapy, certain patients are at high risk of bleeding complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal: patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to: suturing of the blood vessel (native anastomosis or grafts) / organ, infection, trauma, radiation.Patients without adequate wound hemostasis.Patients who have been administered anticoagulants or platelet aggregation inhibitors.Patients who do not have adequate tissue coverage over vascular structures.If v.A.C.® therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.If active bleeding develops suddenly or in large amounts during v.A.C.® therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop v.A.C.® therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.® therapy units and dressings should not be used to prevent, minimize or stop vascular bleeding.Protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Always ensure that v.A.C.® foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.Consideration should also be given to the negative pressure setting and therapy mode when used when initiating therapy.Caution should be taken when treating large wounds that may contain hidden vessels which may not be readily apparent.The patient should be closely monitored for bleeding in a care setting deemed appropriate by the treating physician.Hemostasis, anticoagulants and platelet aggregation inhibitors: patients without adequate wound hemostasis have an increased risk of bleeding, which, if uncontrolled, could be potentially fatal.These patients should be treated and monitored in a care setting deemed appropriate by the treating physician.Caution should be used when treating patients on doses of anticoagulants or platelet aggregation inhibitors thought to increase their risk for bleeding (relative to the type and complexity of the wound).Consideration should be given to the negative pressure setting and therapy mode when initiating therapy.
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