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

Model Number WNDACT

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged toe issues and hospitalization are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a significant history of co-morbidities including history of venous stasis, right hallux osteomyelitis with a bone debridement and antibiotic therapy, as well as a recent revascularization on the right lower extremity.Kci has made multiple unsuccessful attempts to obtain additional clinical information.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.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: check the therapy hour meter to ensure that 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.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)(6) 2020, the following information was reported to kci by the patient: the activ.A.C.¿ therapy system allegedly caused issues with the patient's toes and the patient was hospitalized.No other information is available.Per review of kci records dated (b)(6) 2020, the patient has a significant history of co-morbidities.It was also documented prior to v.A.C.® therapy placement that the right hallux did not exhibit signs of healing.On (b)(6) 2020, the physician prescribed v.A.C.® therapy for 1 month indicating v.A.C.® therapy could assist with the wound healing.On (b)(6) 2020, the patient's spouse contacted kci to let us know that the patient is still attached to the v.A.C.® therapy.A device evaluation for activ.A.C.¿ therapy system is pending completion.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci's assessment remains the same: it cannot be determined that the alleged toe issues and hospitalization are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.

Event Description

On 18-mar-2020, 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) 2020, the device was placed with the patient.On 22-jun-2020, 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, kci's assessment remains the same; it cannot be determined that the alleged toe issues and hospitalization requiring amputation are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.

Event Description

On 12-jun-2020, the following information was reported to kci by the physician: the patient missed all appointments after receiving the activ.A.C.¿ therapy system.The patient's wife mentioned that the patient was admitted in another hospital and his toes were amputated.No additional information is available.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio, tx
• MDR Report Key: 10151013
• MDR Text Key: 197600492
• Report Number: 3009897021-2020-00235
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 06/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN.; DOXYCYCLINE HYCLATE.; INSULIN LISPRO.
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 57 YR
• Patient Weight: 103