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

Model Number WNDARM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Rash (2033); Fungal Infection (2419)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged infection, rash, and redness are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.There was excess drainage under the v.A.C.® drape after the patient fixed the dressing.The device passed quality control checks before and after patient placement.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: schemia to the incision or incision area; untreated or inadequately treated infection; inadequate hemostasis of the incision; cellulitis of the incision area.

Event Description

On 28-oct-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 a yeast infection developing on the surrounding skin.The skin reportedly exhibited a rash and redness.On (b)(6) 2020, the patient reportedly fixed the dressing and drainage sat under the v.A.C.® drape.The patient was placed on antibiotics and antifungal medication.On 29-oct-2020, the following information was reported to kci by the nurse, "the patient developed an infection allegedly from the excess drainage under the v.A.C.® drape.An antifungal powder was used to treat the infection." on 24-nov-2020, device evaluation was performed, and there was no fault, or failure found in kci quality engineering to substantiate the customer complaint.The device passed qc checks and met specifications at the kci service center before placement, and after placement at kci qe.The device passed the pressure accuracy checks and maintained pressure at 125 mm hg.In addition, the unit produced alarms as expected during standard qc alarm testing and produced no unexpected alarm events during evaluation on the test board in kci qe under nominal operating conditions.The source of the blockage alarms seen in the event logs was most likely external to the device as the device generated no unexpected alarms and maintained a firm dressing seal during evaluation at kci qe.

• 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
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 10908973
• MDR Text Key: 218911130
• Report Number: 3009897021-2020-01034
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2018
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 92