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

Model Number WNDARM

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Decrease in Suction (1146); Gas/Air Leak (2946)

Patient Problem Bacterial Infection (1735)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged infections diagnosed (b)(6) 2021 are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The staphylococcus aureus infection resolved with antibiotics, however the wound was still positive for proteus bacteria per the results of the second culture.The patient reportedly dropped the activ.A.C.¿ ion progress¿ remote therapy monitoring system numerous times during use.Additionally, the patient was diagnosed with weeping edema prior to placement and experienced seal issues with the v.A.C.® drape due to the edema and patient non-compliance; therefore, the event is being reported due to potential use error.The device passed quality control specifications before and after patient placement.Device labeling, available in print and online, states: warnings: 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.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.

Event Description

On (b)(6) 2021, the following information was reported to kci by the family member: on (b)(6) 2021, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was reportedly not working and exhibiting leaks and the device was removed.The family member stated the device may have been bumped or dropped.On (b)(6) 2021, the following information was reported to kci by the nurse: on (b)(6) 2021, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to a visible air leak with no alarms exhibiting from the device.The patient has reportedly dropped the device numerous times and the device may not be working properly.The patient has weeping edema, contributing to the v.A.C.® drape not adhering to the skin.The nurse states there are seal issues even while the dressing is secured with an ace¿ elastic bandage [non kci product].It was also reported that the patient has pulled off the v.A.C.® dressings numerous times without notifying the healthcare provider.The patient's wound keeps getting infected allegedly due to the seal issues and the device not alarming.The patient is about to start a second round of antibiotics since initiation of v.A.C.® therapy.On (b)(6) 2021, the following information was reported to kci by the nurse: the patient initiated v.A.C.® therapy post debridement of below knee amputation.The patient has developed two infections since initiating v.A.C.® therapy.The results of the first culture, received on 18-nov-2021, were positive for two types of bacteria.The results of the second culture, received on 10-dec-2021, identified that one of the initial bacterial infections had resolved; however, the wound was still positive for the other bacterial infection as well as a new type of bacteria.The patient was treated with intravenous antibiotics for both events.No surgical intervention was required.The nurse stated they are not sure if the reported infections were related to v.A.C.® therapy or other issues because they had a lot of problems keeping a seal.The patient reportedly transfers around unassisted without care of device location.Additionally, the patient manipulates the dressing causing small air leaks that are not big enough to trigger alarms.The device reportedly continues to operate and maintains pressure, but it is wet underneath the v.A.C.® drape.The nurse alleged maceration is noted and is considered reversible.The nurse stated the patient's weeping edema may have caused or contributed to the leaking and v.A.C.® drape not adhering.The nurse also reported the patient scratches around the dressing.No additional information available.On (b)(6) 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.On (b)(6) 2021, the device was tested per quality control procedure by 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.Refer to mdr 3009897021-2022-00004 for the new infection diagnosed on (b)(6) 2021.

• 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: 13176303
• MDR Text Key: 288667336
• Report Number: 3009897021-2022-00003
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• 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: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White