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

Model Number WNDARM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fungal Infection (2419); Tissue Breakdown (2681)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

Additional information regarding v.A.C.® simplace¿ dressing: lot #: a01185v009.Expiration date: 31-dec-2024.Unique identifier (udi) #: (b)(4).Device manufacture date: 13-jan-2022.Based on the information provided, it cannot be determined that the alleged wound increase in size and the alleged fungal infection requiring medication is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a history of previous wound dehiscence with wound infection, requiring hospitalization and antibiotic therapy at the time of v.A.C.® therapy placement.A device evaluation is pending return of the device.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.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 (b)(6) 2022, the following information was reported to kci by the patient: the wound is getting larger in size around the edges and a rash has developed to area around the wound.The physician ordered nystatin to apply to skin and it is helping.On (b)(6) 2022, the following information was reported to kci by the home health nurse: the patient was never placed on nystatin, however, an order was obtained on (b)(6) 2022 for lotrisone cream.On (b)(6) 2022, the following information was reported to kci via clinical records: on (b)(6) 2022, the home care registered nurse indicates that the distal incision area is larger compared to the last measurements.Nurse discussed with vascular surgeon and verbal order was obtained to discontinue v.A.C.® therapy and apply dry sterile gauze to incision areas.Nurse also discussed possible fungal rash at right groin/perineal area.The vascular surgeon stated an order for nystatin will be sent to the pharmacy.Nurse applied an over-the-counter (otc) herbal anti-fungal powder to the periwound.On (b)(6) 2022, the nurse indicated the periwound rash to distal and proximal groin wounds has worsened.An order for antifungal cream was obtained from the primary care physician.A device history record review for the v.A.C.® simplace¿ dressing lot number a01185v009 was completed.All end release testing of the product and packaging met specifications.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending return of the device.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged wound increase in size and the alleged fungal infection requiring medication is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a history of previous wound dehiscence with wound infection, requiring hospitalization and antibiotic therapy at the time of v.A.C.® therapy placement.The device passed quality control checks and met specifications before and after placement with the patient.

Event Description

On 17-aug-2022, a device evaluation was completed by kci quality engineering.On 20-jun-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 17-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.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING 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: 15209788
• MDR Text Key: 297703915
• Report Number: 3009897021-2022-00132
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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: ASPIRIN 81 MG DAILY; ATORVASTATIN 80 MG AT BEDTIME; COLACE 100 MG TWICE PER DAY; GABAPENTIN 400 MG AT BEDTIME; SPIRONOLACTONE 25 MG DAILY; TOPAMAX 150 MG TWICE PER DAY; TOPROL XL 25 MG DAILY; WARFARIN 12.5 MG DAILY
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female