MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. RENASYS EZ; NEGATIVE PRESSURE WOUND THERAPY MACHINE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem Discharge (2225)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

The wound care clinician went to do a dressing change to patient's abdominal wound that had a wound vac dressing on.This wound was 24cm long, 2.5cm in width and 2cm in depth.She noticed before she began the dressing change that the lower portion of the black foam didn't appear to be sucked down appropriately and that there was drainage present that she could press on and it "squished" to the peri-wound tissue.The upper portion of the black foam was sucked down with the raisin appearance.The negative pressure was at 120mmhg.The lower portion of black foam was near the penrose drain that has a 1 piece colostomy bag covering the drain and collecting drainage.There appears to be leaking into the black foam area and has compromised the negative pressure therapy of the dressing.When she removed the dressing she made sure to assess that the 2 pieces of black thin foam were touching as they need to be to have reticulation (communication between multiple pieces of foam to continue to have negative pressure throughout a wound).The alarm did start to beep when she actively removed the dressing from the patient's wound as if there was a leak, this was before she turned off the machine.The manufacturer will be picking up machine and checking it out.Also will follow up with the wound care clinician.

• Brand Name: RENASYS EZ
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY MACHINE
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 2225 cedars rd ste a; lawrenceville GA 30043
• MDR Report Key: 3766506
• MDR Text Key: 19020354
• Report Number: 3766506
• Device Sequence Number: 1
• Product Code: OMP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2014
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Age: 91 YR
• Patient Weight: 81