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

Model Number WNDINF

Device Problems Low Audible Alarm (1016); Complete Loss of Power (4015)

Patient Problem Bacterial Infection (1735)

Event Date 05/01/2008

Event Type  Injury  

Manufacturer Narrative

Age or date of birth and sex: patient identifier information for two additional patients are as follows: 51 year old female and 46 year old male.Date of event: the specific date is unknown.The article noted patients included were orthopedic trauma patients treated with npwt between may-2008 and nov-2008.Therefore, (b)(6) 2008 was utilized.Based on the information available, it cannot be determined that the alleged three deep infections requiring urgent, unplanned irrigation and debridement were related to the infov.A.C.¿ therapy system.The author was unable to provide additional clinical and device information.No device identifiers were available, therefore, device evaluations could not be performed.Device labeling, available in print and online, states: warning: keep v.A.C.® therapy on: never leave a v.A.C.® dressing in place without active v.A.C.® 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 from an unopened sterile package and restart v.A.C.® therapy, or apply an alternate dressing at the direction of the treating physician.Dressing changes wounds being treated with the v.A.C.® therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48-72 hours, but no less than 3 times a week, with frequency adjusted by the clinician as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48-72 hours; the dressing changing intervals should be based on a continuing evaluation of the wound condition and the patient's clinical presentation, rather than a fixed schedule.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.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.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.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.

Event Description

The following information was received by kci after review of journal article: "the incidence of wound complications related to negative pressure wound therapy power outage and interruption of treatment in orthopaedic trauma patients", which noted the following under section results: "twelve patients (10%) had problems with the npwt device powering off causing an unrecognized interruption of therapy." three of the twelve patients recognized as having failed npwt of this type ultimately experienced deep infections requiring urgent, unplanned surgical irrigation and debridement."unit was left unplugged depleting the device's battery power and the device shut off.As such, many medical machines, including the vac device, have an alarm that signals impending power failure.Medical alarms should be robust and the magnitude of devices alerting failures should be proportional to the potential complications caused by failure." on (b)(6) 2022, the following information was provided to kci by the author/physician: no additional information regarding the article is available.The infov.A.C.¿ therapy system product identifiers were not available, therefore, device evaluations could not be performed.

• Brand Name: INFOV.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 ; 2102556438
• MDR Report Key: 15492793
• MDR Text Key: 300651086
• Report Number: 3009897021-2022-00156
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

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 Model Number: WNDINF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/27/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female