MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C.® DRESSING; OMP

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Osteomyelitis (4533)

Event Date 12/27/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided to kci by the patient: on (b)(6) 2022 the patient slept all day and woke up (b)(6) 2022 to find the activ.A.C.¿ ion progress¿ remote therapy monitoring system had allegedly turned off, so the patient powered the device back on.The device was allegedly off again on (b)(6) 2022 so the patient powered the device back on, and the device was operating at the prescribed setting of 125 mmhg.The patient reported the v.A.C.® dressing has not been changed since 21(b)(6) 2022 due to holiday closure of the wound care center.On (b)(6) 2022, the following information was provided to kci by the registered nurse: on (b)(6) 2022, the patient was seen at the wound care center and the wound did not look good.The patient was sent for an x-ray of the right foot and v.A.C.® therapy was placed on hold.The x-ray indicated osteomyelitis was present in the foot.The patient did not mention during the appointment of issues with the device powering off.Additionally, the v.A.C.® dressing was half-way off the wound when the patient arrived.The patient has been non-compliant with his wound care and did not show up for his appointment on (b)(6) 2022 to have the v.A.C.® dressing changed.On (b)(6) 2023, the following information was provided to kci by the registered nurse: on 04-jan-2023, the patient was hospitalized and had a wound debridement.The patient remains hospitalized at this time.V.A.C.® therapy has been discontinued due to patient non-compliance.The v.A.C.® dressing type and lot number were not provided and the product was not returned; therefore, a device evaluation and a device history record review could not be performed.The alleged osteomyelitis and device turned off is reported under mdr-3009897021-2023-00005.The alleged osteomyelitis and v.A.C.® dressing was not changed from (b)(6) 2022 through (b)(6) 2022 is reported under mdr-3009897021-2023-00007.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged osteomyelitis and subsequent hospitalization and wound debridement are related to the v.A.C.® dressing.A device evaluation and a device history record review could not be performed.The nurse reported that the patient is non-compliant with wound care and missed his wound care appointment on 23-dec-2022, leading to the v.A.C.® dressing remaining in place for six days, beyond the manufacturer's recommendations.Therefore, this event is being reported due to potential use error.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.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.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.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.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 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.

• Brand Name: V.A.C.® DRESSING
• 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: 16246897
• MDR Text Key: 308176025
• Report Number: 3009897021-2023-00007
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLARITIN 10 MG DAILY; DEMADEX 60 MG DAILY; DUONEB 3ML VIA NEBULIZATION AS NEEDED; GABAPENTIN 600 MG THREE TIMES PER DAY; JARDIANCE 10 MG DAILY; LIPITOR 20 MG DAILY; MAGNESIUM OXIDE 400 MG TWICE PER DAY; MIRAPEX 1 MG THREE TIMES PER DAY; POTASSIUM CHLORIDE 10 MEQ TWICE PER DAY; PROTONIX 40 MG DAILY; THIAMINE 100 MG DAILY; VITAMIN D2 1.25 MG ONCE PER WEEK; ZEBETA 10 MG DAILY
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 92 KG