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 Failure of Implant (1924)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

An incorrect fda establishment identification (fei) number was inadvertently used in mdr-previously submitted on 12-feb-2024 for the following fields.All other information was correct for the reported event.Based on the information provided, it cannot be determined that the alleged graft failure was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.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: 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.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 (b)(6) 2024: the following information was provided to kci by the patient: on (b)(6) 2024, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed.It was alleged the device "sucked off her skin graft" causing her muscle and tendon to protrude from wound.On 08-feb-2024, the following information was provided to kci by the nurse: on (b)(6) 2024, the patient was seen by surgeon.The graft was intact but was determined to be nonviable, potentially due to v.A.C.® therapy, and was removed.The patient's muscle was noted to be protruding into the wound.The surgeon was concerned it may have been due to the activ.A.C.¿ ion progress¿ remote therapy monitoring system and therapy was held.The nurse confirmed the tendon was exposed prior to v.A.C.® therapy.There were no alarms or malfunctions reported while the activ.A.C.¿ ion progress¿ remote therapy monitoring system was in place.The patient is expected to be scheduled for additional graft surgery.Due to the patient's medical history, the wound has not shown any signs of improvement, nor has there been any further deterioration.On 15-dec-2023, 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)2023, the device was placed with the patient.Multiple unsuccessful attempts have been made to retrieve the device; therefore, a device evaluation could not be performed.

• 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 ; 2102556436
• MDR Report Key: 18770681
• MDR Text Key: 336185206
• Report Number: 3009897021-2024-00007
• Device Sequence Number: 1
• Product Code: OMP
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2022
• 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): Disability; Other
• Patient Age: 62 YR
• Patient Sex: Female