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 Problem Patient Problem/Medical Problem (2688)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged debridement with increased wound size is related to the activ.A.C.¿ therapy system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.Device labeling, available in print and online, states: precautions 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 10-jan-2020, the following information was reported to kci by the nurse: the patient's wound sized allegedly increased post sharp debridement.The exact date of the debridement was not documented.The patient had no signs or symptoms of infection.The patient continued using v.A.C.® therapy.A device evaluation of the activ.A.C.¿ therapy system is currently pending completion.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci's assessment remains the same: it cannot be determined that the alleged debridement with increased wound size is related to the activ.A.C.¿ therapy system.

Event Description

On 10-sep-2019, 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) 2019, the device was placed with the patient.On 12-feb-2020, 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 that would impact the device's ability to administer v.A.C.® therapy.

• 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: 9683998
• MDR Text Key: 188480109
• Report Number: 3009897021-2020-00055
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 67