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

Model Number 66800694

Device Problems Device Alarm System (1012); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

On arrival, gauze not sucked down, film all loose at ankle and exudate all over the floor.Pump was on but not alarming.

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.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 leak alarm is designed to trigger if the system detects a significant leak.A potential cause of the pump not triggering a leak alarm with a dressing and exudate leaking out at the wound site 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.There is no indication from the complaint description that the pump was malfunctioning however this cannot be verified since the device was not returned for evaluation.A definitive root cause could not be determined at this time.

Event Description

On arrival, gauze not sucked down, film all loose at ankle and exudate all over the floor.Pump was on but not alarming.

• Brand Name: RENASYS - F 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: 3643399
• MDR Text Key: 4352835
• Report Number: 3006760724-2014-00015
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082211
• 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,Followup
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/15/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other