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

Model Number WNDARM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient had a prior diagnosis of osteomyelitis.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.Device labeling, available in print and online, states: warning: 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 alternate 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.Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected 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 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.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.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 appropiate antibiotic therapy.Protect intact bone with a single layer of non-adherent material.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 31-aug-2022, the following information was provided to kci by the patient: the nurses were allegedly not applying the v.A.C.® dressing properly, had excessive leak alarms, and went to the emergency room.The patient alleged the drainage was not being pulled out and was diagnosed with an infection.Will reportedly require an additional surgery on (b)(6) 2022.On 01-sep-2022, the following information was provided to kci by the clinical manager: the patient is at high risk for infections but also failed to report the v.A.C.® alarms to the home health agency in a timely manner.The alarms were going off for a couple of hours until their staff was informed.Nurse went out to see the patient yesterday, but he had already been off v.A.C.® therapy for some time and had a wet to dry dressing in place.Unable to confirm if the infection is new or related to prior diagnosis of osteomyelitis.On 14-sep-2022, the following information was provided to kci by the physician: the patient had a pseudomonas infection which tends to grow in a wet environment.The patient accumulated excessive drainage in the wound, but stated this could have been from the osteomyelitis.Was not aware of any technical issues that the patient had with the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Unable to say what caused the infection.On 15-sep-2022, the following information was provided to kci by the clinical manager: the patient's wound was debrided on (b)(6) 2022 due to the infection.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.

Manufacturer Narrative

Based on the additional information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a prior diagnosis of osteomyelitis.The device passed quality control checks before and after patient placement.

Event Description

On (b)(6) 2022, 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 unit passed the quality control checks and met specifications.On (b)(6) 2022, the device was placed with the patient.On (b)(6) 2022, 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.

• 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: 15525501
• MDR Text Key: 300999442
• Report Number: 3009897021-2022-00152
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• 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: 09/08/2022
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• 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
• Treatment: AMOXICILLIN-CLAVULANATE 875-125 MG, TAKE 1 TABLET.; ASPIRIN 81 MG, TAKE 1 TABLET BY MOUTH EVERY MORNIN; COLLAGENASE OINTMENT, APPLY 1 APPLICATION TOPICAL.; INSULIN DETEMIR U-100, 100 UNIT/ML, INJECT 8 UNITS.; LATANOPROST 0.005% OPHTHALMIC SOLUTION, 1 GTT BOTH.; LOSARTAN 50 MG TABLET, TAKE 1 TABLET BY MOUTH DAIL; METFORMIN 500 MG TABLET, TAKE 1 TABLET BY MOUTH.; SIMVASTATIN 20 MG TABLET, TAKE 1 TABLET BY MOUTH.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male