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

Model Number WNDARM

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Bacterial Infection (1735); Erythema (1840); Tissue Breakdown (2681)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged infection, devitalized tissue, and erythema are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.An evaluation of the device is currently pending completion.The nurse reported that the activ.A.C.¿ therapy system was accidentally turned off by the patient during the night with no indication or evidence that the dressing was changed.This event is being reported as a potential use error.Device labeling, available in print and online, states: keep v.A.C.® therapy on: 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 alternative dressing at the direction of the treating physician.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 25-mar-2021, the following information was provided to kci by the patient: on (b)(6) 2021, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to a wound infection.On 12-apr-2021, the following information was provided to kci by the nurse: the patient's wound developed an infection allegedly due to the patient accidentally turning the v.A.C.® therapy off during the night.No additional information available.Per clinical notes: on (b)(6) 2021, the patient reported odor has been present the past two days.The physician noted odor present in the wound with some surrounding erythema and devitalized skin and subcutaneous tissue.On (b)(6) 2021, the physician noted the patient is on an alternate dressing as v.A.C.® therapy was placed on hold last week.Patient is on day seven of antibiotic therapy.Wound cultures grew staphylococcus aureus.Wound noted to have some surrounding erythema and some slight induration with no odor present.Patient will continue antibiotic therapy for an additional ten days and restart v.A.C.® therapy.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.

Event Description

On 13-may-2021, a device evaluation was completed by quality engineering.On 25-feb-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 12-may-2021, the device was tested per quality control procedure by kci quality engineering 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

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged infection, devitalized tissue, and erythema are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.The nurse reported that the activ.A.C.¿ therapy system was accidentally turned off by the patient during the night with no indication or evidence that the dressing was changed.This event is being reported as a potential use error.

• 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: 11721573
• MDR Text Key: 263413338
• Report Number: 3009897021-2021-00098
• 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
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2021
• 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: 04/09/2021
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 54