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

Model Number WNDARM

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

Patient Problems Cellulitis (1768); Pain (1994); Swelling (2091); Tissue Breakdown (2681)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged cellulitis, swelling, erythema, hospitalization, increase in the wound size are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.It is unknown if the cellulitis that was present prior to initiating v.A.C.® therapy resolved or if the patient was on v.A.C.® therapy after 30-mar-2020.On 13-feb-2020, prior to initiating v.A.C.® therapy, it was noted that the patient presented to the wound clinic due to a non-healing ulcer of left lower leg secondary to cellulitis/leg edema and the patient was on an antibiotic regimen.On 02-mar-2020 and 09-mar-2020, it was noted the patient exhibited a large amount of exudate, circumferential erythema and temperature was hot.Additionally, per the patient's family member v.A.C.® therapy was not resumed after 30-mar-2020.Device labeling, available in print and online, states: infected wounds: infected wounds should be monitored closely and may require more frequent dressing changes than noninfected 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.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: 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.Minimal changes in wound size cut the foam slightly smaller than the wound edges for wounds with little depth, to enhance inward epithelial migration.Do not allow the wound edges to roll downward during v.A.C.® therapy.

Event Description

On 01-apr-2020, the following information was reported to kci by the family member: on 30-mar-2020, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed.States the physician said the wound is not making much progress.The family member states that since the patient has been off the v.A.C.® unit it looks like the wound size and drainage have increased.The patient is also experiencing pain.On 07-apr-2020, the following information was reported to kci by the family member: the activ.A.C.¿ ion progress¿ remote therapy monitoring system has not been resumed.The patient underwent a debridement.On 23-apr-2020, the following information was reported to kci by the family member: the physician stated the patient had a wound infection at the last appointment.A culture was not taken nor antibiotics prescribed.The patient is experiencing pain and large amounts of drainage.On 29-apr-2020, the following information was reported to kci by the family member: last week, the patient was admitted to the hospital allegedly due to a wound infection and pain.Patient was not on antibiotics as the physician stated the wound infection was minor.V.A.C.® therapy has not been resumed.On 30-apr-2020, the following information was reported to kci by the nurse: on (b)(6) 2020, the patient presented to wound care appointment with increased pain, redness and purulent drainage.Patient complained of generalized weakness.Patient was admitted to hospital with cellulitis.It was noted that the kci product may have caused the reported event due to the increase in wound size and pain.It was also noted the patient experienced increased swelling and erythema.The patient discontinued the use of the activ.A.C.¿ ion progress¿ remote therapy monitoring system and underwent subcutaneous debridement and began intravenous antibiotic therapy.Per a review of kci records: on 13-feb-2020, prior to initiating v.A.C.® therapy, it was noted that the patient presented to the wound clinic due to a non-healing ulcer of left lower leg secondary to cellulitis/leg edema.Patient is being treated with an antibiotic regimen.A subcutaneous debridement was performed.On 02-mar-2020, it was noted the patient exhibited a large amount of exudate, circumferential erythema and temperature was hot.On 09-mar-2020, it was noted the patient exhibited a large amount of exudate, circumferential erythema and temperature was hot.A device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.

Event Description

On 07-feb-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 15-may-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 obtained regarding the device, kci's assessment remains the same: it cannot be determined that the alleged cellulitis, swelling, erythema, hospitalization, increase in the wound size are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio, tx
• MDR Report Key: 10016525
• MDR Text Key: 189709654
• Report Number: 3009897021-2020-00177
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLINDAMYCINLEVAQUIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 159