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The date of the event is based on the date of last transmission.The exact date of the event is not available.Based on the information provided, it cannot be determined that the alleged re-admission and bleeding are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.The device evaluation results are currently pending review.Device labeling, available in print and online, states: warnings 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.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 18-jan-2020, the following information was provided to kci: the home health agency reportedly sent the patient to the hospital due to bleeding and the patient was re-admitted to the hospital allegedly for a wound related event.No additional clinical or device information was provided.Kci records noted the patient was using an activ.A.C.¿ ion progress¿ remote therapy monitoring system, and the last update was noted as (b)(6) 2021.On 10-feb-2021, a device evaluation was completed.Device evaluation results are currently pending review.
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Mdr-3009897021-2021-00028_121639-iss submitted on 17-feb-2021 noted the following: section b4 describe event or problem: on 10-feb-2021, a device evaluation was completed.Section d4 unique identifier (udi) #: na.Correction: section d4 unique identifier (udi) #: (b)(4).Section b4 describe event or problem: on (b)(6) 2021, a device evaluation was completed by quality engineering.Based on the additional information provided, kci's assessment remains the same; it cannot be determined that the alleged readmission and bleeding are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.The device passed quality control checks before and after placement.
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On (b)(6) 2021, a device evaluation was completed by quality engineering.On (b)(6) 2021, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2021, the device was placed with the patient.On (b)(6) 2021, the device was tested per quality control procedure by kci quality engineering and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.
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