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 Impaired Healing (2378)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it could not be determined that the alleged hardened area around the wound was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Furthermore, it is not clear if the hardened area around the wound is the same as the area of hypergranulation tissue that required chemical cauterization.The patient has an extensive history of excisional mass removal procedures.Kci has made multiple unsuccessful attempts to obtain additional clinical information.A device evaluation is currently pending completion.Device labeling, available in print and online, states: 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 21-jun-2021, the following information was reported to kci by the patient: on (b)(6) 2021, v.A.C.® therapy was placed on hold allegedly due to a hardened area around the wound.On 06-jul-2021, the following clinical records from the physician were received by kci which noted the following: on (b)(6) 2021, the patient presented for a follow up wound assessment with their surgeon.Hypergranulation tissue to the wound was noted and treated with silver nitrate.There were no signs or symptoms of infection noted and v.A.C.® therapy was not resumed at that time.The patient was advised to follow up with the physician as needed.No additional information was provided.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 obtained regarding the device, kci's assessment remains the same; it could not be determined that the alleged hardened area around the wound was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.

Event Description

On (b)(6) 2021, a device evaluation was completed by quality engineering.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 quality engineering 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
• MDR Report Key: 12196184
• MDR Text Key: 262433180
• Report Number: 3009897021-2021-00170
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/23/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 72