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

Model Number WNDACT

Device Problems Device Alarm System (1012); Decrease in Suction (1146); Fluid/Blood Leak (1250)

Patient Problems Necrosis (1971); Tissue Breakdown (2681)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged wound deterioration, tissue necrosis, and sharp debridement are related to the activ.A.C.¿ therapy system.The device passed quality control checks before and after placement.Device labeling, available in print and online, states: warnings- keep v.A.C.® therapy on: never leave a vac 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.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 31-aug-2021, the following information was provided to kci by the home health nurse: the patient was seen today by the wound care center and the doctor indicated the wound is getting deeper, red and raw allegedly due to the activ.A.C.¿ therapy system not suctioning properly, not alarming and drainage leaking around the wound.On 03-sep-2021, the following information was provided to kci via clinical records from the wound care center: the progress note dated (b)(6) 2021 indicated the wound bed had yellow slough, tan colored eschar and was deteriorated due to increase in necrotic tissue within wound bed.The periwound area is broken down due to blocked v.A.C.® tubing and accumulation of drainage underneath drape with prolonged contact to skin.The progress note dated (b)(6) 2021 indicated the wound bed had brown slough and black, boggy eschar.On 17-sep-2021, the following information was provided to kci by the wound care center nurse: on (b)(6) 2021, the provider noted that the periwound was excoriated, the wound depth had increased, and a sharp debridement was performed to remove necrotic eschar.The provider note comment indicated "given continued v.A.C.® issues despite attempts to mitigate and troubleshoot, ongoing issues with adherence and lack of exudate management persists, likely contributing to the ulcer/periwound skin regression".On 23-feb-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 24-sep-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.

Manufacturer Narrative

Mdr-3009897021-2021-00237 submitted on 30-sep-2021 noted the following: section b3 date of event: (b)(6) 2021.Correction section b3 date of event: (b)(6) 2021.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• MDR Report Key: 12554416
• MDR Text Key: 274550975
• Report Number: 3009897021-2021-00237
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Device Catalogue Number: 340020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR