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

Model Number WNDACT

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Suction Failure (4039)

Patient Problems Bacterial Infection (1735); Tissue Breakdown (2681)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the bilateral groin wounds allegedly increasing in size and the alleged infection requiring antibiotics and debridements are related to the activ.A.C.¿ therapy system.It was anticipated by the ordering physician that the patient would require serial debridements at the time of v.A.C.® placement.The patient has multiple high-risk comorbidities to include morbid obesity, diabetes, rheumatoid arthritis, pulmonary dysfunction, severe peripheral arterial disease, and long-term use of immunosuppressing medications.The patient has an excessive amount of daily output from the bilateral groin wounds.The device met specifications before and after patient placement.Device labeling, available in print and online, states: warning: never leave a v.A.C.® 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 alternate dressing, such as a wet to moist gauze, as approved during times of extreme need, by treating physician.Precautions the v.A.C.® therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area.Untreated or inadequately treated infection.Inadequate hemostasis of the incision.Cellulitis of the incision area.Infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as wound conditions, treatment goals.Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients / caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.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.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.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 03-aug-2022, the following information was reported to kci by the patient's family member: the patient's wounds have allegedly become larger over the last two weeks.The doctor allegedly stated that the activ.A.C.¿ therapy system is not alarming and not suctioning, because fluid is not being suctioned from the wound and has leaked from the dressing site.The doctor did not indicate that the wounds becoming larger were due to the reported technical issues.On 05-aug-2022, the following information was reported to kci by the certified wound care associate: the patient has bilateral groin wounds that allegedly became larger and were cultured on (b)(6) 2022.The culture was positive for infection and the patient was placed on antibiotics and has received multiple debridements in the clinic.The patient has had an excessive amount of drainage, filling up 2-3 canisters per day, and although canisters are filling up with exudate, the patient has continuous pooling of fluid underneath the dressing, allegedly leading to infection.The patient is morbidly obese and has multiple comorbidities to include possible lymphatic system issues.On 12-aug-2022, a device evaluation was completed by kci quality engineering.On (b)(6) 2022, the device was tested per quality control procedure by kci service center, and the device passed and met specifications.On (b)(6) 2022, the device was placed with the patient.On 09-aug-2022, the device was tested per quality control procedure by kci service center and the device passed 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
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 15322132
• MDR Text Key: 298908516
• Report Number: 3009897021-2022-00141
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• 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: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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: 08/04/2022
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2008
• 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
• Treatment: ALBUTEROL 2.5MG VIA NEBULIZATION 3 TIMES PER DAY; AMLODIPINE 5 MG TABLET TWICE PER DAY; ATORVASTATIN 20 MG DAILY; BACLOFEN 20 MG AT BEDTIME AS NEEDED FOR SPASMS; BREO ELLIPTA 100-25 MCG - INHALE ONCE DAILY; BREWER'S YEAST 680 MG TABLET DAILY; CLONIDINE 0.1 MG TWICE PER DAY AS NEEDED; CORLANOR 2.5 MG TABLET TWICE PER DAY; DEXAMETHASONE 4MG - INJECT AS DIRECTED; FOLIC ACID 1 MG DAILY; GABAPENTIN 600 MG EVERY 6 HOURS AS NEEDED; GAMMAGARD 10% INJECTION, MONTHLY; GUANFACINE 2 MG TAB TWICE PER DAY; HYDROCHLORATHIAZIDE 12.5 MG DAILY; HYDROCORTISONE 10 MG TABLET EVERY EVENING; HYDROCORTISONE 20 MG TABLET EVERY MORNING; IRON 325 MG ONCE DAILY; METHOTREXATE SODIUM 2.5 MG - 3 TABS WEEKLY; MS CONTIN 30 MG ER, EVERY 12 HOURS AS NEEDED; NITROGLYCERIN 0.4 MG SUBLINGUAL, AS NEEDED X 3; ONDANSETRON 4 MG EVERY 8 HOURS; OXYCODONE 10 MG TABLET EVERY 12 HOURS AS NEEDED; PANTOPRAZOLE 40 MG DAILY; PLAQUENIL 200 MG - TWO TABLETS DAILY; TRIAMCINOLONE 0.1% TOPICAL CREAM TO AFFECTED AREAS; VENTOLIN HFA 90MCG INHALE TWO PUFFS EVERY 4-6 HOUR; VITAMIN B-1 50 MG DAILY; VITAMIN B-12 ER 2000 MCG ER, ONCE DAILY; VITAMIN D 50,000 IU DAILY
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female