MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800697

Device Problems Device Alarm System (1012); Disconnection (1171); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2013

Event Type  malfunction  

Event Description

Failure to alarm.Main power on and running disconnected from patient and capped off.Was disconnected upon arrival however wasn't alarmed even while it was running and capped off.No alarm when reconnected to patient's dressing that was lifted and leaking.

Event Description

Failure to alarm.Main power on and running disconnected from patient and capped off.Was disconnected upon arrival however wasn't alarmed even while it was running and capped off.No alarm when reconnected to patient's dressing that was lifted and leaking.

Manufacturer Narrative

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

Manufacturer Narrative

The reported complaint is considered inconclusive, the referenced device was not returned for evaluation within a reasonable time for the closure of the investigation.Review of complaints history for renasys ez plus serial # (b)(4) indicates no other complaint has been reported against this device.Loss of dressing adhesion could be attributed to a combination of factors such as wound location, constant friction, pressure directly applied to wound site, accumulation of moisture underneath the dressing, and proper preparation of the periwound skin as per clinical guidelines.Per information provided, wound was located in the sacral area with the patient in the supine position are particularly difficult to seal.In regards to a pump not triggering a blockage alarm while tubing was disconnected and capped off as described it is most likely due to device malfunction, however, without a technical evaluation it could not be confirmed.No further action is considered necessary at this time.There are no indications of patient injuries or harm associated with this issue.If more relevant information is provided at a later date this complaint could be re-opened and reviewed accordingly.The complaint is recorded and any similar issues will be monitored through the complaint system.

• Brand Name: RENASYS EZ PLUS
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• 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: 3833562
• MDR Text Key: 4400451
• Report Number: 3006760724-2014-00368
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K102001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/20/2013
• Date Manufacturer Received: 01/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1