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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged fungal infection requiring medication is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending return of the device.Device labeling, available in print and online, states: warnings: keep v.A.C.® therapy on: 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 alternative dressing at the direction of the treating physician.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.Precautions the v.A.C.® therapy system will not be effective in addressing complications associated with the following: - ischemia to the incision or incision area - untreated or inadequately treated infection - inadequate hemostasis of the incision - cellulitis of the incision area infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as wound conditions and treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warm thin the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.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 22-may-2024, the following information was provided by the patient: on 20-may-2024, v.A.C.® therapy was placed on hold due to an alleged yeast infection around the wound site; nystatin powder was prescribed for a few days and v.A.C.® therapy is scheduled to resume today.On 03-jun-2024, the following information was provided by the home health agency: on 20-may-2024, the home health nurse noted a periwound yeast infection that was being treated with nystatin powder.On 23-may-2024, subsequent home nurse visit occurred and there was no mention of periwound yeast infection at this time.V.A.C.® therapy was reapplied.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending return of the device.
Additional Manufacturer Narrative
Based on the additional information regarding the device, it cannot be determined that the alleged fungal infection requiring medication is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before placement.An evaluation of the device after patient placement could not be performed.
Event or Problem Description
On 18-apr-2024, the device was tested per quality control procedure by the 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.The patient declined to return the device; therefore, a device evaluation could not be performed.

• 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: 19519836
• Report Number: 3009897021-2024-00037
• Device Sequence Number: 20387488
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: RTMGSM01/US
• Device Catalogue Number: RTMGSM01/US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2018
• 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.; LEXAPRO 10 MG - DAILY.; MULTIVITAMIN - DAILY.; OMEPRAZOLE 10MG DELAYED RELEASE - 2 CAPSULES DAILY.; PROBIOTIC FORMULA ¿ 1 CAPSULE DAILY.; VITAMIN B12 2500 MCG ¿ DAILY.; VITAMIN D3 400 IU (10 MCG) ¿ DAILY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female