MAUDE Adverse Event Report: KINETIC CONCEPTS, INC ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	RTMGSM01/US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged bleeding event requiring surgery is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Multiple unsuccessful attempts have been made to obtain additional clinical information.The device passed quality control checks and met specifications before and after patient placement.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 c.F.R.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 (b)(6) 2024, the following information was provided by the patient: on (b)(6) 2024, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was allegedly not working properly and she was instructed to remove the v.A.C.® dressing.The patient removed the v.A.C.® therapy dressing and had a large amount of bloody drainage and presented to the emergency room.The wound was allegedly surgically closed, and she was discharged on (b)(6) 2024.No additional information was provided.On 09-aug-2024, a device evaluation was completed by solventum quality engineering.On 17-jun-2024, the device was tested per quality control procedure by a solventum service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2024, the device was placed with the patient.On 06-aug-2024, the device was tested per quality control procedure by a solventum 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, it was determined the alleged bleeding event is not considered a serious injury and was unrelated to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.
Event or Problem Description
On (b)(6) 2024, the following information was provided by the physician: the patient experienced a minor bleeding episode that resolved with application of gentle pressure.The bleeding was unrelated to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The activ.A.C.¿ ion progress¿ remote therapy monitoring system was ordered to progress wound to a stage where a delayed primary closure could be performed.This goal was achieved, and the wound was surgically closed.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 19955820
• Report Number: 3009897021-2024-00048
• Device Sequence Number: 13002292
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K063692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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
• Device Model Number: RTMGSM01/US
• Device Catalogue Number: RTMGSM01/US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female