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

Model Number	WNDARM
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged osteomyelitis and subsequent hospitalization and wound debridement are 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: warning: 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 alternate dressing, such as a wet to moist gauze, as approved during times of extreme need, by treating physician.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, 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 warmth in 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.Foot wounds for wounds on the plantar surface or heel of the foot, it is best to use a bridging technique to ensure that additional pressure is not applied as a consequence of the placement of the tubing and / or sensat.R.A.C.¿ pad.This involves using foam to allow placement of the sensat.R.A.C.¿ pad or tubing on the dorsum of the foot.-appropriate off-loading of the foot is essential in order to maximize the therapeutic benefit of v.A.C.® therapy.Clinical considerations for diabetic foot ulcers.As with any treatment for diabetic foot ulcers, success depends on accurate diagnosis and the management of underlying disease in combination with effective debridement of non-viable tissue.Off-loading is essential for successful healing of diabetic foot ulcers.Early identification and prompt treatment of infection is essential to prevent complications.In patients with diabetes, this may be difficult as classic signs such as pain, erythema, heat and purulence may be absent or decreased.Special dressing techniques may be considered.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.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 27-dec-2022, the following information was provided to kci by the patient: on (b)(6) 2022, the patient slept all day and woke up (b)(6) 2022 to find the activ.A.C.¿ ion progress¿ remote therapy monitoring system had allegedly turned off, so the patient powered the device back on.The device was allegedly off again on (b)(6) 2022 so the patient powered the device back on, and the device was operating at the prescribed setting of 125 mmhg.The patient reported the v.A.C.® dressing has not been changed since (b)(6) 2022 due to holiday closure of the wound care center.On 29-dec-2022, the following information was provided to kci by the registered nurse: on (b)(6) 2022, the patient was seen at the wound care center and the wound did not look good.The patient was sent for an x-ray of the right foot and v.A.C.® therapy was placed on hold.The x-ray indicated osteomyelitis was present in the foot.The patient did not mention during the appointment of issues with the device powering off.Additionally, the v.A.C.® dressing was half-way off the wound when the patient arrived.The patient has been non-compliant with his wound care and did not show up for his appointment on (b)(6) 2022 to have the v.A.C.® dressing changed.On 17-jan-2023, the following information was provided to kci by the registered nurse: on (b)(6) 2023, the patient was hospitalized and had a wound debridement.The patient remains hospitalized at this time.V.A.C.® therapy has been discontinued due to patient non-compliance.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending return of the device.The alleged osteomyelitis and device turned off is reported in this mdr report.The alleged osteomyelitis and v.A.C.® dressing was not changed from(b)(6) 2022 through (b)(6) 2022 is reported under mdr-3009897021-2023-00007.
Event or Problem Description
On 09-feb-2023, a device evaluation was completed by kci quality engineering.On (b)(6) 2022, the device was tested per quality control procedure by kci service center, and the device passed and met specifications.On (b)(6) 2022, the device was placed with the patient.On 09-feb-2023, the device was tested per quality control procedure by kci service center and the device passed 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 information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged osteomyelitis and subsequent hospitalization and wound debridement are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks and met specifications before and after placement with the patient.

• 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: 16246873
• Report Number: 3009897021-2023-00005
• Device Sequence Number: 17720386
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/27/2023

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: 12/29/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: CLARITIN 10 MG DAILY.; DEMADEX 60 MG DAILY.; DUONEB 3ML VIA NEBULIZATION AS NEEDED.; GABAPENTIN 600 MG THREE TIMES PER DAY.; JARDIANCE 10 MG DAILY.; LIPITOR 20 MG DAILY.; MAGNESIUM OXIDE 400 MG TWICE PER DAY.; MIRAPEX 1 MG THREE TIMES PER DAY.; POTASSIUM CHLORIDE 10 MEQ TWICE PER DAY.; PROTONIX 40 MG DAILY.; THIAMINE 100 MG DAILY.; VITAMIN D2 1.25 MG ONCE PER WEEK.; ZEBETA 10 MG DAILY.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 92 KG