MAUDE Adverse Event Report: KCI USA,INC. ACTIV.A.C.® THERAPY; OMP

Model Number WNDACT

Device Problem Pumping Problem (3016)

Patient Problem Impaired Healing (2378)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged wound failing to progress and the wound getting larger is related to v.A.C.® therapy.Kci has made numerous unsuccessful attempts to obtain additional information.No additional information has been provided.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.

Event Description

On (b)(6) 2015, the following information was reported to kci by the nurse: on (b)(6) 2015 it was first noted that the unit started losing suction and would not hold pressure.The nurse alleged that the unit not holding pressure may have contributed to the wound failing to progress.On (b)(6) 2015, the following information was reported to kci by the nurse: the wound had not just stalled, but had gotten bigger due to the unit not holding suction pressure.The patient was seen at another facility between the dates of (b)(6) 2015 to last visit on (b)(6) 2015 and in between that time the wound measurements had gotten larger.On (b)(6) 2015, the following information was reported to kci by the nurse: the patient had a debridement done while at another facility and the wound measurements were larger due to the debridement.The debridement was done because the unit had failed to hold pressure causing the patient's wound to fail to progress and get worse.She could not verify the exact date of the debridement because the other facility did not provide the information.At the patient's last visit the wound was improving with no further intervention required.On (b)(6) 2015, kci quality engineering (qe) completed the device evaluation and determined the following: on (b)(6) 2015, the device was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications prior to patient placement.On (b)(6)2015, the device was placed on the patient.On (b)(6) 2015, the device was tested per qc procedure by kci field service.The device again passed qc checks and met specifications.The unit was then transferred back into customer storage from (b)(6) 2015.The device was retrieved from storage and forwarded to kci qe for evaluation on (b)(6) 2015.Kci qe completed an evaluation that determined the device passed the pressure accuracy checks and maintained pressure at 125 mm hg.The unit produced audible and visual alarms as intended during qc alarm testing and did not produced any unexpected alarms.Kci qe was not able to confirm the complaint.

• Brand Name: ACTIV.A.C.® THERAPY
• Type of Device: OMP
• Manufacturer (Section D): KCI USA,INC.; san antonio TX
• Manufacturer Contact: paul arrendel ; 6203 farinon drive; san antonio, TX 78249 ; 2105154108
• MDR Report Key: 5321305
• MDR Text Key: 34197083
• Report Number: 3009897021-2015-00119
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063692
• 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: 12/22/2015

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2015
• 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: 25 YR