|
Model Number WNDARM |
Device Problems
Decrease in Suction (1146); Decrease in Pressure (1490); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Bacterial Infection (1735)
|
Event Date 12/06/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Based on information provided, it cannot be determined that the alleged infection and debridement are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient had a chronic non-healing infected wound prior to initiating v.A.C.® therapy.It is not clear if the infection resolved after the second round of antibiotics was completed.A device evaluation is currently pending completion.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.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.Protect periwound skin: consider use of a skin preparation product to protect periwound skin.Do not allow foam to overlap onto intact skin.Protect fragile/friable periwound skin with additional v.A.C.® drape, hydrocolloid or other transparent film.Multiple layers of the v.A.C.® drape may decrease the moisture vapor transmission rate, which may increase the risk of maceration.If any signs of irritation or sensitivity to the drape, foam or tubing assembly appear, discontinue use and consult a physician.To avoid trauma to periwound skin, do not pull or stretch the drape over the foam dressing during drape application.Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.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 that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of 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.
|
|
Event Description
|
On (b)(6) 2020, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly experienced a technical issue.The v.A.C.® simplace¿ dressing lot number was not available.On (b)(6) 2020, the following information was reported to kci by the patient: on (b)(6) 2020, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to an infection.The patient underwent a debridement and wound culture were obtained, date unknown.Patient was placed on antibiotics for ten days and v.A.C.® therapy will resume upon completion.The v.A.C.® simplace¿ dressing lot number in use was 8069897v007.On 19-jan-2021, the following information was reported to kci by the physician: per the provider, at the (b)(6) 2020 visit, the patient's wound surface area and volume improved slightly but the undermining measured larger than the previous week.Additionally, an odor was present and the patient's exudate had changed to purulent.The patient reported the activ.A.C.¿ ion progress¿ remote therapy monitoring system was replaced on (b)(6) 2020 due to a technical issue and the patient did not have suction for several days.On (b)(6) 2020, a wound culture was taken and antibiotics were prescribed.The culture came back positive and a different antibiotic was prescribed to cover the organism identified in the culture.At the (b)(6) 2021 visit, the surface area and volume slightly improved, but the undermining measured larger again.The activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold and was not re-started after that date.Per the physician's notes, the patient did report having seal issues throughout the week of (b)(6) 2020.On 20-jan-2021, following information was reported to kci by the physician: the potential adverse event date was noted as (b)(6) 2020.It was noted the device may have contributed to the event allegedly due to a technical issue with the activ.A.C.¿ ion progress¿ remote therapy monitoring system.It was noted the patient underwent surgical debridement, antibiotic treatment and discontinuation of the device.On (b)(6) 2021, the last culture had no growth and the patient is improving off v.A.C.® therapy but the patient has not healed yet.A review of clinical records provided to kci noted the following: on (b)(6) 2020, prior to initiating v.A.C.® therapy, it was noted the patient's wound exhibited undermining, signs and symptoms of infection and slough.The patient's wound underwent debridement and the patient was prescribed antibiotics.On (b)(6) 2020, it was noted the patient's wound exhibited undermining, signs and symptoms of infection and slough.The patient underwent surgical debridement to remove slough.The patient was prescribed systemic antibiotics.On (b)(6) 2020, it was noted the patient's wound exhibited undermining, signs and symptoms of infection and slough.The patient underwent surgical debridement to remove slough.The patient completed the first round of antibiotics and was prescribed a second round of antibiotics.On (b)(6) 2020, it was noted the patient's wound exhibited undermining, signs and symptoms of infection and slough.The wound bed does appear clean and healthy.The patient underwent surgical debridement to remove slough.The patient completed the second round of antibiotics.It was noted the patient accidently pulled the v.A.C.® tubing off of the wound.On (b)(6) 2020, it was noted antibiotics were prescribed due to slight decline that may be related to the technical issues experienced with the wound v.A.C.®.Wound debrided and culture taken.On 19-jan-2021, a device history record review for v.A.C.® simplace¿ dressing lot number 8069897v007 was completed.All end release testing of product and packaging met specifications.A device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.
|
|
Event Description
|
On 26-oct-2020, the device was tested per quality control procedure by a kci service center, and the unit passed and met specification.On (b)(6) 2020, the device was placed with the patient.On 07-dec-2020, the device was returned to kci, experienced pressure fluctuation during post placement quality control checks, and the pump was replaced.Additional analysis is being conducted by kci quality engineering.On 21-may-2021, a device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system was completed by kci quality engineering.The contribution of the alleged pressure issues to the alleged infection and debridement is indeterminate based on the information gathered during the kci device repair.
|
|
Manufacturer Narrative
|
Mdr-3009897021-2020-00010_121171-iss submitted on 20-jan-2021 noted the following: section b5 describe event or problem: a device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.Correction: section b5 describe event or problem: on 26-oct-2020, the device was tested per quality control procedure by a kci service center, and the unit passed and met specification.On (b)(6) 2020, the device was placed with the patient.On 07-dec-2020, the device was returned to kci, experienced pressure fluctuation during post placement quality control checks, and the pump was replaced.Additional analysis is being conducted by kci quality engineering.Based on the corrections and the additional information regarding the device, kci's assessment remains the same.It cannot be determined that the alleged infection and debridement are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The contribution of the alleged pressure issues to the alleged events is indeterminate based on the information gathered during the kci device repair.
|
|
Search Alerts/Recalls
|
|
|