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

Model Number WNDULT

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

Patient Problems Cellulitis (1768); Ecchymosis (1818)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged bruising to the periwound and cellulitis are related to the v.A.C.Ulta¿ therapy system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.The device passed quality control checks before and after placement.Device labeling, available in print and online, states: keep v.A.C.® therapy and v.A.C.Veraflo¿ therapy on: never leave a v.A.C.® dressing or v.A.C.Veraflo¿ therapy dressing in place without active v.A.C.® therapy or v.A.C.Veraflo¿ 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 or v.A.C.Veraflo¿ therapy dressing from an unopened sterile package and restart therapy; or apply an alternative dressing at the direction of the treating clinician.Infected wounds: 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 and v.A.C.Veraflo¿ therapy parameters (for the v.A.C.Ulta¿ therapy system).Refer to dressing application instructions (found in v.A.C.® dressing and v.A.C.Veraflo¿ 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 a physician immediately to determine if v.A.C.® therapy or v.A.C.Veraflo¿ therapy should be discontinued.

Event Description

On (b)(6) 2022, the following information was reported to kci by the nurse: the v.A.C.Ulta¿ therapy system with v.A.C.Veraflo¿ therapy was utilized on the patient's foot wound with a two-hour dwell time.The dwell time was switched to a one-hour cycle.The patient allegedly developed a large purple bruise adjacent to the wound within twenty-four hours.The device was removed, and there was purple bruising allegedly to the periwound.Redness crept up the leg and the patient developed chills.The patient was diagnosed with cellulitis and treated with intravenous antibiotics.The "facility is unsure if v.A.C.® caused this, but did note that it all happened within 24 hours of making the dwell time switch." no additional information provided.On (b)(6) 2022, 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) 2022, the device was placed with the patient.On (b)(6) 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.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

• Brand Name: V.A.C.ULTA¿ 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: 14675109
• MDR Text Key: 293877202
• Report Number: 3009897021-2022-00120
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554001244
• UDI-Public: 0100849554001244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDULT
• Device Catalogue Number: 350000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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; Hospitalization
• Patient Sex: Female