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

Model Number WNDACT

Device Problem Pressure Problem (3012)

Patient Problem Sepsis (2067)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, kci could not determine that the alleged wound becoming septic and subsequent hospitalization was related to the activ.A.C.¿ therapy system.It was noted the patient had prior evidence of a wound infection and the physician plans to resume v.A.C.® therapy.An evaluation of the device is currently pending completion.Device labeling, available in print and online, states: standard precautions always follow standard precautions standard precautions are designed to reduce the risk of transmission of microorganisms from both known and unknown sources of infection.These precautions can be applied to all patients, regardless of their diagnosis or presumed infection status, and should be used when contact is anticipated with blood and all body fluids.This also included secretions and excretions (except sweat) regardless of whether blood is visible or not, non-intact skin (i.E., open wounds) and mucus membranes.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.Osteomyelitis: v.A.C.® therapy should not be initiated on a wound with untreated osteomyelitis.Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected bone (if necessary), and appropriate antibiotic therapy.Protect intact bone with a single layer of non-adherent material.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) 2021, the following information was provided to kci by the patient's family member: the patient was admitted to the hospital due to the wound becoming septic.It was reported the patient experienced technical issues with the activ.A.C.¿ therapy system not maintaining pressure prior to the event.No additional information was provided.Review of records noted the following: per medical records provided on (b)(6) 2020 from the wound care center, it was noted the patient presented for a wound evaluation on (b)(6) 2020 due to a deteriorating unstageable pressure ulcer to the left trochanter extending down into the trochanteric bursa and "beginning to show a wet gangrene picture".An urgent surgical debridement with plan to obtain intraoperative cultures was scheduled and v.A.C.® therapy was ordered.Patient was to follow up with an infectious disease clinic and wound care center on an outpatient basis.Per medical records provided on (b)(6) 2020 from the physician, it was noted the patient underwent a complete trochanteric bursectomy and biopsy of "deep retained peribursal wound soft tissue for diagnosis and culture-specific antibiotic treatment as or if indicated for possible ongoing trochanteric soft tissue wound infection." per medical records provided on (b)(6) 2021 from the physician, it was noted v.A.C.® therapy was medically necessary due to a highly exudating stage iv left trochanteric pressure ulcer with underlying osteomyelitis to prevent further breakdown.Device evaluation for the activ.A.C.¿ therapy system is currently pending completion.

Event Description

On (b)(6) 2021, a device evaluation was completed by quality engineering.On (b)(6) 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 (b)(6) 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 information obtained regarding the activ.A.C.¿ therapy system, kci's assessment remains the same; kci could not determine that the alleged wound becoming septic and subsequent hospitalization were related to the activ.A.C.¿ therapy system.The activ.A.C.¿ therapy system passed quality control checks before and after patient placement.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• MDR Report Key: 11805487
• MDR Text Key: 249987301
• Report Number: 3009897021-2021-00111
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• 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: 09/01/2021

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: WNDACT
• Device Catalogue Number: 340020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 100