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 Problems Abscess (1690); Bacterial Infection (1735)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date of the incident is unknown.The article noted the patient underwent transplant surgery in november 2017 and indicated the event occurred day 79 post-transplant; therefore (b)(6) 2018 was used.Based on the information provided, it cannot be determined if the alleged infection was related to the activ.A.C.¿ therapy system.It was noted that the patient was in a immunosuppressed state post-operative renal transplant with comorbidities which may predispose to developing further sepsis, particularly in the setting of persistent microbial colonization of the wound, which can occur despite the use of nwpt.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, and instillation therapy parameters (for v.A.C.Instill® therapy system).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.

Event Description

On 20-apr-2021, the following information was received by kci after a review of journal article, lam, s., et al.Case rep transplant.24-sep-2019; 2019: 2452857.Doi: 10.1155/2019/2452857.Surgical site infections complicating the use of negative pressure wound therapy in renal transplant recipients noted the following: page 2 under case 2 noted a patient underwent a deceased donor renal transplant in november 2017.At day 19 post-transplant, the recipient developed a new clinically evident superficial abdominal wall collection above the deep fascia.There were no signs of spreading infection.The wound was re-opened at the bedside, swabbed for mcs [microscopy, culture, and sensitivities], washed out with copious saline irrigation, and debrided until clean, and the wound base was clean and intact with evidence of granulation.The npwt [negative pressure wound therapy] with black foam was applied at negative 125 mmhg continuous pressure.This initial wound swab mcs was negative for organisms at this stage.On day 59 post-transplant, during a routine dressing change, a new collection of turbid fluid was detected beneath the foam, anterior to the fascia.This wound appeared infected, with slough at the base; therefore, it required copious washout and debridement in the operating theatre, until the wound base appeared clean and intact and npwt was then reapplied.This wound swab mcs revealed a penicillin sensitive staphylococcus aureus, and the recipient was treated with oral flucloxacillin.At 79 days post-transplant, the recipient developed urinary sepsis and acute kidney injury along with a concurrent abscess in the abdominal wall, deep to the npwt foam, which was detected on ct [computer tomography] scan of the abdomen and pelvis.The npwt dressings were immediately removed at the bedside, the wound appeared infected, with abscess and was again swabbed and washed out.The npwt was abandoned due to recurrent abscess formation around the foam.This was then replaced with a regimen of simple gauze dressings.The wound swab mcs grew staphylococcus aureus, mixed skin flora and coliforms, whilst the urine mcs was positive for escherichia coli and klebsiella pneumoniae.The recipient received empirical intravenous tazobactam and piperacillin (tazocin) and changed to ceftriaxone based on sensitivities, for a total of 2 weeks.The wound subsequently healed at 109 days post-transplant with a combination of gauze dressings and antibiotics.By this stage the recipient had ongoing normal allograft function.Under discussion noted: although the mechanisms associated with the onset of infectious complications with the use of npwt in our cases are not totally clear, the immunosuppressed state of renal transplant recipients may predispose them to developing further sepsis, particularly in the setting of persistent microbial colonization of the wound, which can occur despite the use of nwpt.Furthermore, alterations in the bacterial flora of the wound can lead to the proliferation of some sub types, such as staphylococcus aureus.Which was evident in case 2.Obesity is a known risk factor for abdominal wall complications in renal transplant recipients, and it is possible that it may also be associated with further ssi in the setting of npwt noting the average bmi of 35.6 kg/m2 in our cases.Under conclusions noted: the use of npwt can often successfully promote wound healing of the open abdominal wall in this particular cohort.However, our case series demonstrates that in immunosuppressed transplant recipients, there may be ineffective bioburden clearance associated with the npwt and antimicrobial use, which can lead to further infections ensuing.The activ.A.C.¿ therapy system identifier was not provided; therefore, a device evaluation could not be performed.Refer to mdr-3009897021-2021-00113 for the event that occurred at 59 days post-transplant.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 11855175
• MDR Text Key: 264602151
• Report Number: 3009897021-2021-00112
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• 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: 340003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR