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

Model Number WNDULT

Device Problems Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Tissue Breakdown (2681); Localized Skin Lesion (4542)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Additional information for v.A.C.Veraflo¿ dressing: lot #: 5061304v002; expiration date: 31-aug-2021; unique identifier (udi) # (b)(4).Additional information for v.A.C.Veralink¿ cassette: lot #: 5182155v003; expiration date: 31-oct-2021; unique identifier (udi) # (b)(4).Based on the information provided, it cannot be determined that the alleged deterioration, plaque, exacerbation of the infection and wound odor are related to the v.A.C.Ulta¿ therapy system.It is unknown if and what medical or surgical intervention was performed.Soft tissue infections are an uncommon manifestation of salmonellosis.An infection with salmonella bacteria typically affects the gastrointestinal system in humans, and fecal matter is one of the most common transport mechanisms for this infection.There have been only a few reports in literature which describe skin and soft tissue infections related to salmonella species.The v.A.C.Ulta¿ therapy system passed quality control checks and met specifications before and after placement with the patient.Device history record reviews for the v.A.C.Veraflo¿ dressing and v.A.C.Veralink¿ cassette determined that all end release testing of product and packaging met specifications.Kci is pending evaluation of the v.A.C.Veralink¿ cassette.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 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/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.Verflo¿ therapy should be discontinued.V.A.C.Ulta¿ therapy system precautions: standard precautions: to reduce the risk of transmission of bloodborne pathogens, apply standard precautions for infection control with all patients, per institutional protocol, regardless of their diagnosis or presumed infection status.In addition to gloves, use gown and goggles if exposure to body fluids is likely.Additional precautions for v.A.C.Veraflo¿ therapy: suitable solutions: v.A.C.Veraflo¿ therapy is intended for use with v.A.C.Veraflo¿ therapy disposables and topical wound treatment solutions and suspensions.Only use solutions or suspensions that are: compatible with v.A.C.® dressings and disposable components.Contact your kci clinical account manager for a list of solutions shown to be compatible with v.A.C.® dressings and disposable components.Note: hypochlorous acid solutions applied frequently at high concentrations can lead to significant material degradation.Consider utilizing concentrations and exposure durations as low as clinically relevant.V.A.C.Veraflo¿ blockage alarm (therapy interrupted): during v.A.C.Veraflo¿ therapy the v.A.C.Ulta¿ therapy unit will transition to the soak phase upon initiation of this alarm and will continue to the v.A.C.® therapy phase before repeating the cycle.If blockage is resolved prior to completion of the v.A.C.® therapy phase, the v.A.C.Veraflo¿ therapy cycle will not be interrupted.If alarm condition cannot be resolved, contact kci.V.A.C.® therapy blockage alert: the v.A.C.Ulta¿ therapy unit will continue to attempt to apply therapy during this alert.If alarm condition cannot be resolved, contact kci.V.A.C.® therapy blockage alarm (therapy interrupted): therapy unit remains on; however, negative pressure at the wound site may be below therapeutic value.If alarm condition cannot be resolved, contact kci.Under clinician supervision, replace the v.A.C.® dressing or v.A.C.Veraflo¿ therapy dressing with an alternate dressing if therapy is interrupted for more than two hours.

Event Description

On (b)(6) 2021, the following information was provided to kci by the hospital representative: the v.A.C.Ulta¿ therapy system allegedly exhibited an alarm condition that resolved with a dressing change.Subsequently, post six flushing cycles, the alarm condition recurred.Upon removal of the patient's wound dressings, a significant deterioration with plaque and wound odor were allegedly observed.The v.A.C.Ulta¿ therapy system was discontinued.On (b)(6) 2021, the following information was provided to kci: the patient allegedly exhibited a significant amount of plaque.The clinical staff reported the patient allegedly has a salmonella infection, that has increased "again" post treatment.The patient's wound was being instilled with granudacyn® irrigation solution.On (b)(6) 2021, the following information was provided to kci: the patient presented to the clinic allegedly due to the wound not healing.The patient underwent a debridement and v.A.C.Veraflo¿ dressing was placed prophylactically.After the first dressing change, the patient's wound reportedly appeared clean with granulation, and a second surgery was planned.Subsequently, the wound allegedly worsened post therapy failure.The patient was placed on antibiotic therapy, and the patient's wound is being treated daily with an alternate dressing regimen.The patient reportedly had a wound in the rib area since 2020, and salmonella has been documented in the patient's past medical records.On (b)(6) 2021, the patient's infection allegedly increased.The patient has been discharged from the hospital and is utilizing actisorb¿ dressing.No additional information was provided.On (b)(6) 2021, 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) 2021, the device was placed on the patient.On (b)(6) 2021, 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.On (b)(6) 2021, device history record reviews of the v.A.C.Veraflo¿ dressing lot number 5061304v002 and v.A.C.Veralink¿ cassette lot number 5182155v003 determined that all end release testing of product and packaging met specifications.Kci quality engineering is pending reciept of a v.A.C.Veralink¿ cassette from the same lot number.

Manufacturer Narrative

Based on the additional information provided regarding the v.A.C.Veralink¿ cassette, kci's assessment remains the same; it cannot be determined that the alleged deterioration, plaque, exacerbation of the infection and wound odor are related to the v.A.C.Ulta¿ therapy system.It is unknown if and what medical or surgical intervention was performed.Soft tissue infections are an uncommon manifestation of salmonellosis.An infection with salmonella bacteria typically affects the gastrointestinal system in humans, and fecal matter is one of the most common transport mechanisms for this infection.There have been only a few reports in literature which describe skin and soft tissue infections related to salmonella species.The v.A.C.Ulta¿ therapy system passed quality control checks and met specifications before and after placement with the patient.Device history record reviews for the v.A.C.Veraflo¿ dressing and v.A.C.Veralink¿ cassette determined that all end release testing of product and packaging met specifications.There was no fault found with the returned v.A.C.Veralink¿ cassette.There was no problem detected with the device and no additional clinical information was provided.Therefore, the root cause of the alleged events could not be established.

Event Description

On (b)(6) 2021, a device evaluation of the returned v.A.C.Veralink¿ cassette lot number 5182155v003 was completed.Kci quality engineering determined that there was no fault was found with the returned v.A.C.Veralink¿ cassette.

Manufacturer Narrative

(b)(4) submitted on (b)(6) 2021 noted the following: a1: patient identifier: (b)(6).B3: date of event: (b)(6) 2021.Corrections: a1: patient identifier: (b)(6).B3: date of event: (b)(6) 2021.Based on the corrected data, kci's assessment remains the same; it cannot be determined that the alleged deterioration, plaque, exacerbation of the infection and wound odor are related to the v.A.C.Ulta¿ therapy system.

• Brand Name: V.A.C.ULTA THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antono TX 78249
• MDR Report Key: 12321944
• MDR Text Key: 266642420
• Report Number: 3009897021-2021-00189
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K162790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2021

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: ULTDEV01/DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/07/2021; 09/07/2021
• Supplement Dates FDA Received: 09/16/2021; 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GRANUDACYN® IRRIGATION SOLUTION.
• Patient Outcome(s): Other; Required Intervention