MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS

Model Number 66800697

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Cellulitis (1768); Fever (1858); Unspecified Infection (1930)

Event Date 06/13/2013

Event Type  No Answer Provided  

Event Description

Failure to maintain vacuum.On (b)(6) 2013, physicians and surgeons at (b)(6) emergency room determined that an npwt patient, was suffering from a post operative infection, including fever and cellulitis which required multiple surgeries.Throughout the use of the npwt pump in the care of this patient, the product failed to function properly.More particularly, the pump failed to effectively and safely remove irrigation and bodily fluids, wound exudates and infectious materials.The pump failed to maintain the correct negative pressure ordered by the treating physicians and healthcare providers.

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in a supplement report.

Event Description

Failure to maintain vacuum.On (b)(6), 2013.Physicians and surgeons at (b)(6) determined that an npwt patient, was suffering from a post operative infection, including fever and cellulitis which required multiple surgeries.Throughout the use of the npwt pump in the care of this patient, the product failed to function properly.More particularly, the pump failed to effectively and safely remove irrigation and bodily fluids, wound exudates and infectious materials.The pump failed to maintain the correct negative pressure ordered by the treating physicians and healthcare providers.

• Brand Name: RENASYS EZ PLUS
• Type of Device: RENASYS EZ PLUS
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3932693
• MDR Text Key: 4576925
• Report Number: 3006760724-2014-00392
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 66800697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/17/2014
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1