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

Model Number WNDARM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Cellulitis (1768)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, kci could not determine that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The healthcare provider reported the patient lived alone and had difficulty managing the device due to the patient's advanced age; the patient was reportedly not keeping the device plugged in and leaving the v.A.C.® dressing in place over the manufacturers' recommendation.Because of this, the patient was admitted to a skilled nursing facility for continued wound care due to the patient's lack of a caregiver upon discharge from the hospital.An evaluation of the device is currently pending completion.This event is being reported due to potential use error.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.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 13-sep-2021, the following information was reported to kci by the nurse: on (b)(6) 2021, the patient was admitted to the hospital allegedly due to a wound infection.The patient was reportedly not keeping the device plugged in and leaving the v.A.C.® dressing in place.On 06-oct-2021, the following information was reported to kci by the medical assistant: the patient was last seen by the surgeon on (b)(6) 2021, at which time the wound did not appear infected.Per the inpatient discharge paperwork dated (b)(6) 2021, the discharge diagnosis was cellulitis to the scalp.The patient did have ongoing issues with managing v.A.C.® therapy as the patient was forgetful due to advanced age and did not have a caregiver to provide assistance.The patient was discharged to a skilled nursing facility for this reason for continued wound care.The patient was treated with antibiotics, and the wound has improved.No further information available.Per review of kci records, the patient utilized the device while inpatient until (b)(6) 2021.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending return of the device.

Manufacturer Narrative

Based on the information obtained regarding the device, kci's assessment remains the same; kci could not determine that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The healthcare provider reported the patient lived alone and had difficulty managing the device due to the patient's advanced age; the patient was reportedly not keeping the device plugged in and leaving the v.A.C.® dressing in place over the manufacturers' recommendation.Because of this, the patient was admitted to a skilled nursing facility for continued wound care due to the patient's lack of a caregiver upon discharge from the hospital.The device passed quality control checks before and after patient placement.This event is being reported due to potential use error.

Event Description

On 26-oct-2021, a device evaluation was completed by kci quality engineering.On 22-jul-2021, 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) 2021, the device was placed with the patient.On 26-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.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: 12614897
• MDR Text Key: 275902975
• Report Number: 3009897021-2021-00241
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• 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
• Treatment: AMITRIPTYLINE 25MG TABLET DAILY.; EXFORGE DAILY.; LASIX 40MG TABLET DAILY.; MELATONIN 10MG QHS.; POTASSIUM CHLORIDE ER 10 MEQ DAILY.; PROLIA 60MG/ML INJECTION EVERY 6MONTHS.; TRAMADOL.; AMITRIPTYLINE 25MG TABLET DAILY; EXFORGE DAILY; LASIX 40MG TABLET DAILY; MELATONIN 10MG QHS; POTASSIUM CHLORIDE ER 10 MEQ DAILY; PROLIA 60MG/ML INJECTION EVERY 6MONTHS; TRAMADOL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White