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Based on information provided, it cannot be determined if the alleged bleeding event is related to the v.A.C.Ulta¿ therapy system.Device labeling, available in print and online, states: 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.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.Warnings: 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, bio-engineered tissue or 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.
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On (b)(6) 2018, the following information was reported to kci by the hospital wound care nurse: while attempting to place the device on the patient's wound, she received blockage alarms with no apparent cause.There were no visible clots, but some blood.On (b)(6) 2018, the following information was reported to kci by the hospital wound care nurse: she was unsuccessful in placing the device due to the patient having bleeding.She notified the physician of the events.The physician took over handling the case.She did not know if intervention was needed to resolve the bleeding.No additional information was provided.The device history review for canister lot (6010141) determined that all end release testing met specifications.On (b)(6) 2018, the device passed quality control (qc) checks and met specifications before placement with the patient.On (b)(6) 2018, the device was placed with the patient.On (b)(6) 2018, the device was tested by kci quality engineering per qc procedures and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.This mdr report for patient identifier (b)(6) is associated with mdr report for patient identifier (b)(6) as two units were used.This report assesses unit 1 of 2, serial number (b)(6).
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