MAUDE Adverse Event Report: KINETIC CONCEPTS, INC V.A.C. FREEDOM¿ THERAPY SYSTEM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	320000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As of (b)(6) 2025, it was reported to (b)(4) that a civil rights action had been filed in the united states district court district of (b)(6).In that complaint prepared by the plaintiff, the following information was reported: ¿upon removal of the v.A.C.® granufoam¿ dressing, the wound was noted to have a very strong foul odor and thick layer of slough throughout the middle of the wound.This was noted by the rn on (b)(6) 2022¿the patient started on antibiotics¿on (b)(6) 2022¿(b)(6)] discontinued the v.A.C.Freedom¿ therapy system.The patient started the v.A.C.Freedom¿ therapy system again on (b)(6) 2022¿on (b)(6) 2022¿the patient¿s room had a very strong odor.Right inner thigh of the patient was very, very, red, warm to touch, and ¿very firm.¿ lpn checked right groin area and noticed smell coming from groin area ¿where v.A.C.Freedom¿ therapy system attached.¿ the patient complained of leg hurting throughout the day¿on (b)(6) 2022¿again an odor from the patient¿s groin wound and v.A.C.Freedom¿ therapy system noted.Right thigh area starting to weep, skin is very taut.On (b)(6) 2022, the patient had very, very low blood pressure¿patient left to the hospital by ambulance¿on (b)(6) 2022, surgery was completed at [treating facility] in the morning ¿to irrigate and debride groin wound.¿ the patient was placed on norepinephrine drip due to low blood pressure¿(b)(6) 2022, the patient was still on norepinephrine also iv vancomycin cid and zosyn.The patient¿s right groin wound grew out cultures positive for cocci¿on (b)(6) 2022, the patient returned to [(b)(6)] ¿daptomycin iv to be completed at [(b)(6)] for infection for six days.Use of v.A.C.Freedom¿ therapy system was finally abandoned.Admission diagnosis: severe sepsis with septic shock.Concerns of necrotizing fasciitis, wound cultures positive for staph infection in both groin and lower leg wound¿once the v.A.C.Freedom¿ therapy system was discontinued the patient did not have any further issues with the wound healing.Wounds have since healed completely.¿ no additional information was provided.On (b)(6) 2022, the device was tested per quality control procedure by a (b)(4) service center, and the device passed the quality control checks and met specifications prior to patient placement.On (b)(6) 2022, the device was placed with the patient.The device was returned to solventum on (b)(6) 2022, tested per quality control procedure by a solventum service center and no failures were found with the device related to this event.
Additional Manufacturer Narrative
Based on the information provided, it cannot be determined that the alleged infection is related to the v.A.C.Freedom¿ therapy system.Multiple unsuccessful attempts have been made to obtain additional clinical information.The device passed the quality control checks prior to patient placement and no failures were found with the device related to this event.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

• Brand Name: V.A.C. FREEDOM¿ THERAPY SYSTEM
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• Manufacturer Contact: yvonne mcmann ; 6203 farinon drive; san antonio, TX 78249 ; 2103743188
• MDR Report Key: 22996071
• Report Number: 3009897021-2025-00039
• Device Sequence Number: 12963384
• Product Code: OMP
• UDI-Device Identifier: 00849554006539
• UDI-Public: 0100849554006539
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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
• Operator of Device: Health Professional
• Device Model Number: 320000
• Device Catalogue Number: 320000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown