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 Problem Sepsis (2067)

Event Date 04/15/2022

Event Type  Injury  

Event Description

On 19-apr-2022, the following information was reported to kci by the home health case manager: the patient was admitted to the hospital on (b)(6) 2022 allegedly due to sepsis.No additional information was provided.On 31-mar-2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2022, the device was placed with the patient.Multiple unsuccessful attempts have been made to retrieve the device; therefore, a device evaluation could not be performed.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged sepsis is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Multiple unsuccessful attempts have been made to obtain additional clinical information.It is unknown if and what medical or surgical intervention was required.The device passed quality control checks before patient placement, and a device evaluation after placement could not be performed.Device labeling, available in print and online, states: wound infection call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: you have a fever.Your wound is sore, red or swollen.Your skin itches or you have a rash or redness around the wound.The area around the wound feels very warm.You have pus or a bad smell coming from the wound.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.

Manufacturer Narrative

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged sepsis is related to activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before and after patient placement.

Event Description

On 20-jun-2022, a device evaluation was completed by kci quality engineering.On 20-jun-2022, the device was tested per quality control procedure by kci service center, 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.

• 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: 14359654
• MDR Text Key: 291409953
• Report Number: 3009897021-2022-00091
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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
• Patient Age: 46 YR
• Patient Sex: Female