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

Model Number WNDACT

Device Problem Premature Discharge of Battery (1057)

Patient Problems Necrosis (1971); Impaired Healing (2378); Tissue Breakdown (2681)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, kci could not determine that the alleged worsening of patient condition [devitalized tissue and maceration] requiring sharp debridement was related to the activ.A.C.¿ therapy system.The patient's wound is debrided every wound care visit as a standard of care for the wound etiology.The patient has a diabetic foot ulcer to the first metatarsal head with chronic callus formation and maceration to the plantar aspect.The patient reports offloading the affected extremity as much as possible; however, the patient is the caregiver for their spouse.An evaluation of the device is currently pending completion.Device labeling, available in print and online, states: warnings: osteomyelitis: v.A.C.® therapy should not be initiated on a wound with untreated osteomyelitis.Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected bone (if necessary), and appropriate antibiotic therapy.Protect intact bone with a single layer of non-adherent material.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.Foot wounds: for wounds on the plantar surface or heel of the foot, it is best to use a bridging technique to ensure that additional pressure is not applied as a consequence of the placement of the tubing and / or sensat.R.A.C.¿ pad.This involves using foam to allow placement of the sensat.R.A.C.¿ pad or tubing on the dorsum of the foot.-appropriate off-loading of the foot is essential in order to maximize the therapeutic benefit of v.A.C.® therapy.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.Clinical considerations for diabetic foot ulcers: as with any treatment for diabetic foot ulcers, success depends on accurate diagnosis and the management of underlying disease in combination with effective debridement of non-viable tissue.Off-loading is essential for successful healing of diabetic foot ulcers.Early identification and prompt treatment of infection is essential to prevent complications.In patients with diabetes, this may be difficult as classic signs such as pain, erythema, heat and purulence may be absent or decreased.Special dressing techniques may be considered.

Event Description

On 31-jan-2021, kci reviewed clinical records provided from the wound care center that noted the following: on (b)(6) 2020, the physician noted the patient experienced technical issues with the activ.A.C.¿ therapy system.It was noted the patient was having trouble keeping the device charged and questioned if the device is leaking.Patient admitted to increased activity to provide care for spouse.Per wound assessment, "significant amount of maceration noted to the plantar periwound area.Some maceration in the crease between the second and third metatarsals.Debridement performed using curette to remove devitalized tissue." a non-kci dressing was applied to the central aspect of the wound, an alginate dressing to the plantar aspect, and a hydrocolloid to the periwound area.V.A.C.® therapy was reapplied status post debridement.On 02-mar-2021, the following information was reported to kci by the wound care nurse: the patient has a history of callus formation [devitalized tissue] and maceration to the bottom of foot due to wound location and wound type.The patient utilizes an offloading shoe, but is the sole caretaker for spouse which makes it difficult to stay off foot completely.Per the nurse, the patient had issues with keeping the activ.A.C.¿ therapy system charged which caused fluid to pool at the wound site.The device issues may have contributed to the worsening of the patient's existing condition.The device was exchanged and overall the wound is doing much better with v.A.C.® therapy.Device evaluation for the activ.A.C.¿ therapy system is currently pending completion.

Manufacturer Narrative

Based on the additional information obtained regarding the activ.A.C.¿ therapy system, kci's assessment remains the same; it cannot be determined that the alleged devitalized tissue [maceration] requiring sharp debridement was related to the activ.A.C.¿ therapy system.The wound care nurse confirmed the patient has a known history of callus formation [devitalized tissue] and maceration to the bottom of foot reportedly due to wound location and wound type.The patient allegedly experienced difficulty adequately offloading the wound site as ordered and does have issues keeping the activ.A.C.¿ therapy system charged which reportedly caused fluid to pool at the wound site.The activ.A.C.¿ therapy system 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) 2020, 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) 2020, 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. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 11402625
• MDR Text Key: 240390605
• Report Number: 3009897021-2021-00043
• 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: 04/01/2021

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: WNDACT
• Device Catalogue Number: 340020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 01/31/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 113