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); Skin Infection (4544)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected 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.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.

Event Description

On (b)(4) 2021, the following information was reported to kci by the nurse practitioner: v.A.C.® therapy was placed on hold allegedly due to an infection.On (b)(4) 2021, the following information was reported to kci by the patient: on (b)(4) 2021, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed to give the patient's skin a break allegedly due to some skin irritation.On (b)(4) 2021, the following information was reported to kci by the nurse practitioner: v.A.C.® therapy was placed on hold to allow the periwound skin to heal before resuming v.A.C.® therapy.On (b)(4) 2021, the following information was reported to kci by the nurse practitioner: the patient developed a yeast/fungal infection and v.A.C.® therapy was place on hold for two weeks as the v.A.C.® drape was allegedly not sticking.The skin was treated with an over the counter cream and powder.The nurse practitioner believes the infection was related to v.A.C.® therapy.The patient resumed v.A.C.® therapy.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.A device history record review of the v.A.C.® granufoam¿ dressing is currently pending completion.

Event Description

On (b)(6) 2021, the following information was reported to kci by the nurse practioner: upon assessment on (b)(6) 2021, it was decided to continue the activ.A.C.¿ ion progress¿ remote therapy monitoring system hold as the fungal infection to the peri wound had not completely healed.The nurse confirmed the activ.A.C.¿ ion progress¿ remote therapy monitoring system was never reapplied after the initial hold on (b)(6) 2021.On (b)(6) 2021, a device history record review of the v.A.C.® granufoam¿ dressing was completed.All end release testing of product and packaging met specifications.

Manufacturer Narrative

Additional information for the v.A.C.® granufoam¿ dressing lot number: 60263547v006: d4: expiration date: 31-oct-2023; unique identifier (udi) #: (b)(4).H4: device manufacture date: 09-nov-2020.Based on the additional clinical information and information provided regarding the v.A.C.® granufoam¿ dressing, kci's assessment remains the same; it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The manufacturing records for the v.A.C.® granufoam¿ dressing met specifications.A device evaluation is pending completion.

Event Description

On 26-may-2021, a device evaluation was completed by kci quality engineering.On 24-dec-2020, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specification.On (b)(6) 2020, the device was placed with the patient.The patient declined to return the device; therefore the device is not available for evaluation in kci quality engineering.

Manufacturer Narrative

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The unit passed the quality control checks and met specification prior to placement with the patient, and the patient declined to return the device; therefore the device is not available for evaluation in kci quality engineering.

• 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
• MDR Report Key: 11556090
• MDR Text Key: 244918007
• Report Number: 3009897021-2021-00054
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2021

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: WNDARM
• Device Catalogue Number: 416909
• Device Lot Number: 60263547V006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/14/2021; 05/26/2021
• Supplement Dates FDA Received: 04/30/2021; 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR