MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C. THERAPY SYSTEM; OMP

Model Number WNDACT

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

Patient Problems Swelling (2091); Tissue Damage (2104); Injury (2348)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged wound worsening, swelling and intensive care admission are related to the activ.A.C.¿ therapy system.The physician noted, "i do not see any issues with wounds/problems after review of chart." kci has made multiple unsuccessful attempts to obtain additional clinical information.Device labeling, available in print and online, states: 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.

Event Description

On (b)(6) 2019, the following information was reported to kci by the patient: the patient's wound allegedly became worse as the activ.A.C.¿ therapy system power cord was not provided after he was discharged from the hospital.The patient's wound allegedly experienced swelling, and the patient was admitted to the intensive care unit for four days.No additional information is available.Per review of kci records provided on 25-jul-2019 noted on 19-jul-2019, the right lower extremity exam noted "swelling about the knee." the patient was placed on activ.A.C.¿ therapy system on (b)(6) 2019 and was discontinued on (b)(6) 2019.Per review of kci records provided on 19-nov-2019, the physician noted, "i do not see any issues with wounds/problems after review of chart." the patient reported he has held onto the activ.A.C.¿ therapy system, and the product has not been returned, therefore the a device evaluation could not be performed.

Event Description

On 15-jul-2019, the device was tested per quality control procedure by kci field service, and the unit passed quality control checks and met specifications.On (b)(6) 2019, the device was placed with the patient.Several attempts have been made to retrieve the device and the product was not returned, therefore a device evaluation and a device history review could not be performed.To date, the device has not been returned to kci; therefore, kci quality engineering is not able to perform an evaluation of the device.

Manufacturer Narrative

Based on the additional information provided, kci's assessment remains the same; it cannot be determined that the alleged wound worsening, swelling and intensive care admission are related to the activ.A.C.¿ therapy system.The physician noted, "i do not see any issues with wounds/problems after review of chart." kci has made multiple unsuccessful attempts to obtain additional clinical information.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; 6203 farinon drive; san antonio TX 78249
• MDR Report Key: 9366640
• MDR Text Key: 168270304
• Report Number: 3009897021-2019-00360
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 45 YR
• Patient Weight: 68