MAUDE Adverse Event Report: KINETIC CONCEPTS., INC. V.A.C. DRESSING; OMP

Model Number VACDSP

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

Patient Problems Tissue Breakdown (2681); Fluid Discharge (2686); Insufficient Information (4580)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Device identifier not provided, and device was not returned, therefore a device history review and device evaluation could not be performed.Based on information provided, it cannot be determined that the alleged events are related to the v.A.C.® dressing.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.V.A.C.® therapy was placed on an infected wound and the patient has significant comorbidities that may have contributed to the event.Device labeling, available in print and online, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations: in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.Infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions and 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.

Event Description

On 04-jun-2021, the following information was provided to kci by the director of nursing: on 26-feb-2021, the activ.A.C.¿ therapy system was discontinued allegedly due to the patient's wound deteriorating from the v.A.C.® dressing.The patient is being treated with an antibiotic cream.No additional information was provided.Records review noted the following: v.A.C.® therapy was initiated inpatient on (b)(6) 2021 and transitioned to post-acute v.A.C.® therapy on (b)(6) 2021.On (b)(6) 2021, the patient's wound was observed, and the nurse noted "wound deteriorating due to wound vac dressing" and v.A.C.® therapy was discharged.The patient was placed on silvadene cream with dry dressings.On (b)(6) 2021, the nurse practitioner noted v.A.C.® therapy was discharged due to "drainage and spreading." it was also noted that the patient underwent an irrigation and debridement, date not provided.The v.A.C.® dressing type and identifier were not provided; therefore, a device history review could not be performed.

• Brand Name: V.A.C. DRESSING
• 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: 12111741
• MDR Text Key: 260222475
• Report Number: 3009897021-2021-00161
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 61