MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number	WNDARM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged bleeding event requiring cauterization is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient is on anticoagulation therapy, has a history of severe lower extremity arterial disease, and multiple other potentially contributing comorbidities.A device evaluation is pending return of the device.Device labeling, available in print and online, states: contraindications do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.Warnings 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.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.
Event or Problem Description
On 24-nov-2023, the following information was provided to kci by the patient: on 20-nov-2023, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold allegedly due to bleeding from skin.On 01-dec-2023, the following information was provided to kci by the wound care center nurse: on (b)(6) 2023, the patient was seen at the wound care center and had active bleeding from the wound.Silver nitrate was used to cauterize the wound and v.A.C.® therapy was placed on hold.The cause of the bleeding was unknown, but patient is on anticoagulation medication.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending return of the device.
Event or Problem Description
On 28-feb-2024, a device evaluation was completed by kci quality engineering.On (b)(6) 2023, the device was tested per quality control procedure by a kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2023, the device was placed with the patient.On (b)(6) 2024, the device was tested per quality control procedure by a kci service center and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.
Additional Manufacturer Narrative
Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged bleeding event requiring cauterization is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks and met specifications before and after patient placement.

• Brand Name: ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 18356298
• Report Number: 3009897021-2023-00078
• Device Sequence Number: 17873619
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN 81 MG DAILY - OCT 2023; ATORVASTATIN 40 MG EVERY NIGHT; GABAPENTIN 300 MG THREE TIMES PER DAY; PLAVIX 75 MG ONE TABLET DAILY - OCT 2023; XANAX 1 MG TWICE PER DAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 128 KG