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

Model Number WNDARM

Device Problems Failure to Charge (1085); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The patient's friend reported the patient experienced technical issues "a couple days" prior to the date received by kci; therefore, (b)(6) 2021 was utilized.Based on the information provided, it cannot be determined that the alleged worsening infection requiring further amputation is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The initial wound type was an amputation due to a necrotizing soft tissue infection and osteomyelitis of the left foot complicated by uncontrolled diabetes.The patient reportedly experienced technical issues with the device and a lapse in on-going wound care from appropriately trained personnel.The patient began performing their own dressing changes against the manufacturers' recommendation and reportedly left the v.A.C.® dressing in place over the manufacturers' recommendation; therefore, this event is being reported due to potential use error.A device evaluation is currently pending device return.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.Transition patients between care settings if the post-acute v.A.C.® therapy unit is not available or discharge, and therapy will be off for more than two hours, remove the v.A.C.® therapy dressings before the patient is discharged.Apply an alternative dressing, such as wet to moist gauze, as approved during times of extreme need, until the new v.A.C.® therapy unit is delivered, and appropriately trained personnel are prepared to provide on-going care of the patient.V.A.C.® therapy should not be discharged with a patient if the clinician has a question about the availability of appropriately trained personnel.V.A.C.® therapy dressings should be removed and an appropriate alternative dressing applied until trained personnel are secured by the healthcare provider and a v.A.C.® therapy unit is delivered.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.If a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Osteomyelitis: v.A.C.® therapy should not be initiated on a wound with untreated osteomyelitis.Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected bone (if necessary), and appropriate antibiotic therapy.Protect intact bone with a single layer of non-adherent material.Wound infection call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever.Your wound is sore, red or swollen.Your skin itches or you have a rash or redness around the wound.The area around the wound feels very warm.You have pus or a bad smell coming from the wound.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.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.Deterioration of the wound if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance / expertise of a specialist: if available on the therapy unit, check the therapy history log to ensure the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.

Event Description

On (b)(6) 2021, the following information was reported to kci by the patient's friend: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly stopped working a couple of days ago.The patient had been on the same dressing for approximately three weeks and the dressing was last changed two fridays ago.The patient is not scheduled for a dressing changed until (b)(6) 2021 and is currently on antibiotics and pain medication for a pre-existing infection.The caller reported swelling and pain to the wound.On 07-dec-2021, the following information was reported by the home health: the patient "no-call-no-showed" to all his appointments since surgery in (b)(6).No additional information available.On 07-dec-2021, the following information was reported by the patient: due to issues with scheduling appointments with the wound clinic, the patient has not been seen by the physician.The patient was "changing the dressing the best way they could during this time." the patient did stop using the activ.A.C.¿ ion progress¿ remote therapy monitoring system due to the device not maintaining a charge.The patient ended up going to the hospital and had the remaining toes amputated as the infection was getting worse despite taking the prescribed antibiotics.A device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending return of the device.

Manufacturer Narrative

Based on the additional information received regarding the device, kci's assessment remains the same; it cannot be determined that the alleged worsening infection requiring further amputation is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Due to a lapse in on-going wound care from appropriately trained personnel the patient began performing their own dressing changes against the manufacturers' recommendation and reportedly left the v.A.C.® dressing in place over the manufacturers' recommendation.Kci has made multiple unsuccessful attempts to obtain additional clinical information and retrieve the device.The device passed quality control checks before placement.An evaluation of the device after patient placement could not be performed.Therefore, this event is being reported due to potential use error.

Event Description

On 12-oct-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.Multiple unsuccessful attempts have been made to retrieve the device, therefore, a device evaluation could not be performed.

• Brand Name: ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM
• Type of Device: 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: 12983474
• MDR Text Key: 286160918
• Report Number: 3009897021-2021-00288
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 416909
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 77 KG