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

Model Number WNDARM

Device Problem Fluid/Blood Leak (1250)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681); Blister (4537)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it could not be determined that the alleged blistering, infection and debridement were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.A device evaluation is currently pending completion.Device labeling, available in print and online, states: 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.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 01-sep-2021, the following information was reported to kci via clinical notes provided by the physician's office: on (b)(6) 2021, the patient "experienced a wound vac complication when it kept alarming so an ace wrap was applied to hold the seal.Unfortunately, the patient developed medial, dorsal and lateral foot blistering, which extended the patient's plantar wound width laterally.However, the wound base has been healing in well and the length decreased".On 03-sep-2021, the following information was reported to kci by the clinical coordinator: there was leak from the v.A.C.® drape and patient placed an ace wrap very tightly without informing anyone which caused blisters.On 23-sep-2021, the following information was reported to kci by the physician's assistant: the patient was seen on (b)(6) 2021 and had a wound debridement and cultures were taken.Cultures were positive for infection and patient was referred to infectious disease doctor.The patient's wound width markedly increased in size at visit on (b)(6) 2021 after the v.A.C.® drape seal complication and it was a contributing factor.On 29-sep-2021, the following information was reviewed via clinical notes provided by the physician's office: on (b)(6) 2021, the patient's wound was treated with betadine scrub for cleaning and debridement done with 4 mm curette.Wound was redressed with wet to dry dressing after debridement.The v.A.C.® dressing lot number was not provided, therefore a device history record review could not be performed.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.

Event Description

On 01-oct-2021, a device evaluation was completed by quality engineering.On 12-may-2021, 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) 2021, the device was placed with the patient.On 01-oct-2021, the device was tested per quality control procedure by kci service center 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.

Manufacturer Narrative

Mdr: 3009897021-2021-00236 submitted on 29-sep-2021 noted the following: section d9 device available for evaluation? returned to manufacturer: 28-aug-2021.Correction: section d9 device available for evaluation? returned to manufacturer: 28-sep-2021.Based on the correction and additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged blistering, infection and debridement is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.

• 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: 12548816
• MDR Text Key: 274553970
• Report Number: 3009897021-2021-00236
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE 10MG.; ASPIRIN 81MG.; ATORVASTATIN 80MG.; CHLORTHALIDONE 25 MG.; ERGOCALCIFEROL 1250MCG.; FERROUS FUMARATE 324MG.; GABAPENTIN 100MG.; INSULIN 100UNIT/ML.; KETOCONAZOLE 2% TOPGEL.; LEVOTHYROXINE 200MCG.; LISINOPRIL 10MG.; LOKELMA 10GM.; TRIPLE HELIX COLLAGEN 100% TOP POWDER.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR