MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS F MEDIUM W/ SOFT PORT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800795

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

Failure to alarm.Wound nurse went in to change the patients dressing and found the pump running with the dressing lifted and no alarm sounding.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint is inconclusive since the circumstance cannot be duplicated and no product was returned for evaluation.No lot information was given therefore a review of production records could not be performed.However, the circumstances of the described complaint have occurred before.Since negative pressure therapy involves various elements within a system (i.E.Pump, canister, suction port etc.), it is difficult to determine a definitive root cause for the failure to alarm.A potential cause of the pump not triggering a leak alarm is that there was a blockage in the system at the same time as a leak, resulting in the system being able to hold the required negative pressure.Also, in order for the leak alarm to sound, fluid must have cleared the tubing and a free flow of air must be detected for a specific amount of time.It is possible that there was exudate in the tubing that had not cleared and therefore the alarm did not sound.However, a definitive root cause could not be determined at this time.

Event Description

Failure to alarm.Wound nurse went in to change the patients dressing and found the pump running with the dressing lifted and no alarm sounding.

• Brand Name: RENASYS F MEDIUM W/ SOFT PORT
• 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: 3816592
• MDR Text Key: 17574711
• Report Number: 3006760724-2014-00351
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800795
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/01/2014
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1