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

Model Number WNDACT

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ therapy system.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.Warnings: keep v.A.C.® therapy on: never leave a v.A.C.® dressing in place without active v.A.C.® therapy for more than two hours.If therapy is off for more than two hours, remove the old dressing and irrigate the wound.Either apply a new v.A.C.® dressing from an unopened sterile package and restart v.A.C.® therapy or apply an alternative dressing at the direction of the treating physician.Foot wounds: for wounds on the plantar surface or heel of the foot, it is best to use a bridging technique to ensure that additional pressure is not applied as a consequence of placement of the tubing and/or sensat.R.A.C.¿/t.R.A.C.¿ pad.This involves using the foam to allow placement of the sensat.R.A.C.¿/t.R.A.C.¿ pad or tubing on the dorsum of the foot (consider use of the v.A.C.® granufoam¿ heel dressing).

Event Description

On 01-dec-2020, the following information was reported to kci by the patient: the patient experienced technical issues with the activ.A.C.¿ therapy system and allegedly had an infection, (b)(6).No additional information available.Per the kci records dated on (b)(6) 2020: the patient had cellulitis to the periwound.The previous culture showed (b)(6) for (b)(6).On 14-sep-2020, the device was tested per quality control procedure by a kci service center, passed the quality control checks and met specifications.On (b)(6) 2020, the device was placed with the patient.The device was returned to kci on 22-oct-2020, tested per quality control procedure by a kci service center and no failures were found with the device related to this event.

• Brand Name: ACTIV.A.C. THERAPY 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: 11096033
• MDR Text Key: 231951845
• Report Number: 3009897021-2020-01082
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Device Catalogue Number: 320020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2007
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 145