MAUDE Adverse Event Report: KCI USA, INC. ACTIV.A.C.¿ THERAPY (SYSTEM); OMP

Model Number WNDACT

Device Problem Pumping Problem (3016)

Patient Problem Unspecified Infection (1930)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged hospitalization due to possible wound infection is related to activ.A.C.Therapy (system).There have been multiple attempts made to gather additional information, but there has been no response.It is unknown if medical or surgical intervention was performed.Kci is reporting this event as the impact to the patient is unknown to date.Device labeling, available in print and online, states: 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 and instillation therapy parameters (for the 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 jan 25 2017, the following information was reported to kci by the patient's family member: the family member stated that there was an odor to the wound, the fluid was staying in the tubing, and they were concerned about an alleged infection in the wound.On feb 01 2017, the following information was reported to kci by the home health nurse: the nurse stated the patient was admitted to the hospital on (b)(6) 2017, but had no further information to provide.On feb 20 2017, the following information was reported to kci by the physician's nurse: the nurse stated that the patient was admitted to the hospital on (b)(6) 2017 for an infection to the wound.No additional information was provided.On dec 22 2016, the device was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications.On feb 08 2017, the device was tested per quality control (qc) procedure by kci quality engineering.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit related to the event.

• Brand Name: ACTIV.A.C.¿ THERAPY (SYSTEM)
• Type of Device: OMP
• Manufacturer (Section D): KCI USA, INC.; san antonio TX
• Manufacturer Contact: paul arrendell ; 6203 farinon drive; san antonio, TX 78249 ; 2105154108
• MDR Report Key: 6356917
• MDR Text Key: 68269820
• Report Number: 3009897021-2017-00025
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/24/2017

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: WNDACT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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): Hospitalization; Other
• Patient Age: 70 YR