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 Bacterial Infection (1735); Bacterial Infection (1735); Rash (2033); Rash (2033)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

Additional information for the v.A.C.® granufoam¿ dressing : unique identifier (udi) # (b)(4) ; expiration date : 30-apr-2023.Device manufacture date: 05-may-2020.Based on information provided, it cannot be determined that the alleged rash and infection were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a history of infection and necrotizing fasciitis as well as other comorbidities that could potentially contribute to the alledged event.It is unclear if the previous infection resolved.Kci has made multiple unsuccessful attempts to obtain additional clinical information.Device labeling, available in print and online, states: warnings: 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.

Event Description

Records review noted the following: on (b)(6) 2020, the physician noted the patients wound as improving.The patient "has completed the antibiotic regimen [for an infection that was present prior to initiating v.A.C.® therapy] and today complaining of itching of the surrounding skin at the lower pole of the wound.There is a maculopapular reddened rash present.The wound continues to decrease in size." the patient's care plan was modified to include antifungal lotion and powder.It was noted that tobacco abuse is causing delayed wound healing.On (b)(6) 2020, the physician noted the wound as improving.The patient "continues to complain of itching in and around the wound.There is some redness but not the typical fungal pattern with satellite lesions.There is desquamation around the wound." on (b)(6) 2020, the physician noted the wound as improving with strong odor to drainage.The patient reported there was "a strong odor from the wound and wound vac since monday." a back wound swab for culture and sensitivity was obtained and identified an unspecified bacteria.The patient also reported that "the itching did not improve with application of cavilon and antifungal powder.Decided to stop the wound vac." on (b)(6) 2020, the physician noted the patient's wound as deteriorating with strong odor to drainage.The patient "reported that the dressing leaked a day after last weeks dressing and wanted the wound vac back.[patient] also found to have bacteria in [patient's] wound and has been prescribed 2 different antibiotics" on (b)(6) 2020, the following information was reported to kci by the patient: the patient alleged she had an infection, and a rash from the v.A.C.® drape on the (b)(6) 2020.Activ.A.C.¿ therapy system was removed.The physician reapplied v.A.C.® therapy on (b)(6) 2020 as the could not do daily dressing changes.On (b)(6) 2020, the following information was reported to kci by the patient: on (b)(6) 2020, the patient reportedly observed an odor from the wound, and alleged that a wound infection developed requiring antibiotic therapy and alternate therapy.On (b)(6) 2020, a culture and sensitivity was performed, and the patient is pending the results on (b)(6) 2020.No additional information.On 01-oct-2020, a device history record review for v.A.C.® granufoam¿ dressing lot number 8038895v007 was completed.All end release testing of the product and packaging met specifications.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently 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 rash and infection were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.

Event Description

On 07-jan-2021, kci quality engineering completed an evaluation of the device.On 30-jul-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 04-jan-2021, the device was tested per quality control procedure by kci quality engineering and 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.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 10752580
• MDR Text Key: 214802058
• Report Number: 3009897021-2020-00990
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• 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: 01/29/2021

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 416909
• Device Lot Number: 8038895V007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Treatment: GABAPENTIN - 400 MG
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 67