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

Model Number 66800697

Device Problem Device Alarm System (1012)

Patient Problem Fluid Discharge (2686)

Event Date 07/05/2013

Event Type  malfunction  

Event Description

Failure to alarm: "canister full" alarm did not go off.Contaminated exudate was already seeping out from beneath the dressing.

Manufacturer Narrative

(b)(4).The reported complaint was not confirmed, after the evaluation of the returned device.An evaluation was conducted to the pump as per "renasys ez plus performance and safety check¿.A visual inspection was conducted and no anomalies were noted.The pump was tested per the normal test procedure for alarm functions and is working within specifications.Pump was connected to mains and operated in continuous mode with no anomalies.A blockage/canister full alarm will be triggered by the system if the canister is full or if a blockage it is detected from the t-connector to the canister when the vacuum is set within the recommended therapeutic range (40-120mmhg).The pump was tested per the normal test procedure for alarm functions and is working within specifications.A possible root cause for the issue reported it is most likely due to a true blockage from the clp (t-connector) to the canister.No fault was found with the device during the evaluation, which indicated that the pump was working within specifications.Smith & nephew has issued (b)(4) to initiate renasys product labeling updates.These labelling updates will provide enhanced information on the functionality of the alarms as they relate to the design of the device, and scenarios that can occur in clinical settings which may impact alarm functionality.

• Brand Name: RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
• 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: 3764203
• MDR Text Key: 21531172
• Report Number: 3006760724-2014-00232
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2014

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?: Yes
• Device Operator: Nurse
• Device Model Number: 66800697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2013
• Distributor Facility Aware Date: 07/05/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/05/2013
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other