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

Model Number UNKVAC

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2013

Event Type  Injury  

Manufacturer Narrative

Age at time of event, date of birth: the patient's age was not provided.The article noted the average age for patients included in the "npwt protocol" group was 61.6 years.Sex: females and males were included in this article.Weight: the patient's weight was not provided.The article noted 25 patients had a bmi less than 30, 11 patients had a bmi between 30 and 34.99, 5 patients had a bmi between 35 and 39.99, and 3 patients had a bmi of 40 or greater.Date of event: the specific date is unknown.The article noted patients underwent emergent celiotomy between 01-jul-2013 and 30-jun-2014.The device type/ identifiers were not provided, and the devices were not returned.Based on the information provided, it cannot be determined that the alleged superficial surgical site infections requiring conversion to open npwt were related to the v.A.C.® therapy system.The article noted that none of the sso's in the npwt protocol group required operative re-intervention.It is unknown if and what medical intervention was required to resolve the surgical site infections.The article noted that the kci v.A.C.® therapy unit was utilized with two non-kci dressings which is considered off-label use.The physician could not provide any additional clinical or device information.The device type and identifiers were not provided; therefore, device evaluations could not be performed.The alleged small fascial dehiscence was considered minor and the article noted it was managed nonoperatively; therefore, kci has deemed the reported dehiscence as not reportable.V.A.C.® therapy device labeling, available in print in 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 instillation therapy parameters (for v.A.C.Instill® therapy system).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 (b)(6) 2021, the following information was received by kci after a review of journal article, regner, justin, et al.Comparison of a standardized negative pressure wound therapy protocol after midline celiotomy to primary skin closure and traditional open wound vacuum-assisted closure management.Proc (bayl univ med cent).2018;31 (1): 25-29.Https://doi.Org/10.1080/08998280.2017.1400312.Page 26 defines sso [surgical site outcomes] as post-operative superficial surgical site infections [ssi], deep space ssi, organ space ssi, return to the operating room, and fascial dehiscence.Page 27 noted in table 1: forty-four of the one hundred and fifty-nine patients were in the npwt [negative pressure wound therapy] protocol group.The method used in the npwt protocol group consisted of partially closing the midline wound with staples spaced 0.5 cm apart for 3 cm followed by a 1 cm gap.Hydrofera blue bacteriostatic foam (non-kci dressing) was placed in the 1 cm gap and a silver-impregnated foam dressing, mepilex ag® foam dressing (non-kci dressing) was placed over the incision with a kci v.A.C.® therapy unit attached to the wound.Page 27 noted in table 1: five of the forty-four patients experienced an sso in the npwt protocol group.None of the five patients that experienced an sso required operative re-intervention.Three of the five ssos were superficial ssi's requiring conversion to open npwt.One patient had a small fascial dehiscence that was managed nonoperatively.One patient developed an enterocutaneous fistula.Page 28 under discussion noted "this study has several limitations.First, the study was retrospective chart review and was subject to selection bias.Second, the study was not appropriately powered to detect a difference in sso's, we wound have needed to enroll 670 subjects." on (b)(6) 2021, the following information was provided to kci by the physician: no additional clinical or device information can be provided.The v.A.C.® therapy type and device identifiers were not provided; therefore, a device evaluation could not be completed.Refer to mdr 3009897021-2021-00096 for the one patient that developed an enterocutaneous fistula.Refer to mdr 3009897021-2021-00097 for the three patients that experienced superficial ssi's requiring conversion to open npwt.

• Brand Name: V.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 ; 2102556328
• MDR Report Key: 11721346
• MDR Text Key: 261688101
• Report Number: 3009897021-2021-00097
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other