MAUDE Adverse Event Report: SMITH AND NEPHEW WOUND MANAGEMENT CANISTER 300ML ? RENASYS GO (NO CLP); PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800914

Device Problems Burst Container or Vessel (1074); Device Operates Differently Than Expected (2913)

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

Event Date 10/17/2013

Event Type  malfunction  

Event Description

Defective alarm canister had been changed and a few drop of fluids were observed in the canister as the system was switched on again; the gel sachet had opened and ¿exploded¿ across the inside of the canister, creating a ¿snowstorm effect¿.On observing this the nurses were concerned and the canister was disconnected from the patient¿s dressing and the pump left to run uncapped to see if a blockage had occurred and if the pump would alarm.The pump was quiet, showing no sign of being disconnected from the dressing.The alarm finally sounded after ten minutes, showing initially ¿low vacuum¿ and then ¿leak.¿ the pump serial number was (b)(4), the canister was not on a drip stand, but had been kept upright, on a slight angle.

Manufacturer Narrative

(b)(4).The presence of the solidifier along the inside of the canister is confirmed based on the description of the complaint and the photos attached to the complaint.The solidifier bag is designed to break-down or dissolve in the interaction with exudates.The contents of the bag are meant to exit the bag in order to interact with the exudates with the purpose of gelling exudates contained in canister.While the exact mechanism for the ¿snowstorm effect¿ described is unknown at this time and has not been duplicated through investigation, the delay in the low vacuum and leak alarm was most likely caused by the solidifier temporarily interacting with the filter in the canister.The sequence of events leading to a potential hazard entitled ¿time delay between alarm condition arising and leak alarm sounding¿ was identified with the associated harms of desiccation and pain requiring medication and a marginal severity (minor injury but causes significant discomfort).The canisters use was discontinued immediately after witnessing the solidifier contents on the sides of the canister.The dhr was reviewed and no issues were found during the manufacturing and/or release of the canister device.Complaints will continue to be monitored.Smith & nephew has issued car02714 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: CANISTER 300ML ? RENASYS GO (NO CLP)
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH AND NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH AND 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
• MDR Report Key: 3725263
• MDR Text Key: 4322507
• Report Number: 3006760724-2014-00059
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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?: No
• Device Operator: Other
• Device Model Number: 66800914
• Device Lot Number: 01013P
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/17/2013
• Initial Date Manufacturer Received: 10/17/2013
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1