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

Model Number WNDARM

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Tissue Breakdown (2681)

Event Date 09/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided to kci by the patient: patient reported his wound was doing great, but allegedly appeared to have deteriorated when the physician decided to take the activ.A.C.¿ ion progress¿ remote therapy monitoring system off.The physician recommended the patient go to the hospital for evaluation.Patient was admitted and started on antibiotics for an alleged bone infection.On (b)(6) 2022, the following information was provided to kci by the practice manager: practice manager reports that the alleged wound deterioration and infection were the result of negligence by the nurse.Stated that nurse stopped reporting issues that patient was experiencing with v.A.C.® therapy.Reports that activ.A.C.¿ ion progress¿ remote therapy monitoring system may have contributed to the alleged wound deterioration and infection.No additional information was provided.Per kci record review: device discontinued (b)(6) 2022.Patient sent to hospital.On (b)(6) 2022, the device was tested per quality control procedure by kci field service, and the unit passed quality control checks and met specifications.On (b)(6) 2022, the device was placed with the patient.The patient declined to return the device; therefore, a device evaluation could not be performed.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged wound deterioration and infection requiring hospitalization and medication are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a history of infection and delayed wound healing.There was an infection present prior to placement of the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has significant comorbidities that may be contributing factors in this event.The device passed quality control checks before patient placement, and a device evaluation after placement could not be performed.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.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.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: -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.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.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 Description

On 05-dec-2022, a device evaluation was completed by kci quality engineering.On 03-aug-2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2022, the device was placed with the patient.On 05-dec-2022, the device was tested per quality control procedure by the kci service center and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

Manufacturer Narrative

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged wound deterioration and infection requiring hospitalization and medication 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.

• 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: 15636639
• MDR Text Key: 302057381
• Report Number: 3009897021-2022-00165
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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; Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male