MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT 800CC SEALED CANNISTER; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800423

Device Problems Device Alarm System (1012); Component Missing (2306)

Patient Problem No Information (3190)

Event Date 11/28/2011

Event Type  malfunction  

Event Description

Pumps did not alarm for full canisters and the pumps lost vacuum.

Manufacturer Narrative

This single complaint involves multiple lots for canisters not causing alarms when visibly full.The complaint is confirmed from reenacting the described event with returned samples, as the alarm could not be readily observed and from what is reported, beyond recommended safe level before replacement instructed.The evaluation of complaint samples determined that the root cause of a full canister not triggering a pump alarm was the fit of conforming antimicrobial filters into the ez or ez plus pump in all cases full insertion not required to obtain proper negative pressure and inflow to canisters.The complaint against the 250cc canisters is better understood to cause problems in monitoring canister volumes compared to the 800cc canister as the canister holder covers most of the canister body and graduations.Most users would not rely on the alarm to replace the canisters, but for some users the alarm is expected to indicate a canister has been fully occupied by exudates and suction occluded by resulting gel material.The reenactment of the event also indicated that the canisters are sealing shut from solidifier and overflow protection and vacuum is held enough to prevent backflow into wound site.Since the only circumstances for repeat complaints would be for clinicians waiting for an alarm to replace the canisters, it is advised to fully insert the filter into pump and monitor canister volumes closely in system use.Returned filters were tested to a single canister full of water (fully gelled) and capped, using an ez pump.Initially all returned filters failed to alarm (time 0-3min) as reported on complaints.The returned filters were tested underwater for possible leaks through welds, no leak detected.Some samples were even coated at each seam to prevent a leak.The vendor did an investigation through the supplier of the filters and the dimensional and lot test data showed the filters met their acceptance requirement.Retains from another manufacturer¿s version of same filter were also tested.These were initially considered the ¿good¿ ones as they produced an alarm around 75-85 seconds after pump activation.The engineers measured barb characteristics and looked for differences that would make one version filter alarm but another fail to alarm.Subtle changes in force required to insert each version of filter into same pump were noticed (subjective, comparison only).The picture below shows the current filter (left) and the previous version of the filter (right).As it was proposed to jam the filters in all the way (deeper than what initially achieves suction), the entire set of complaint sample filters alarmed as expected.The key to a good seal around the filter (no air entering between filter and pump) is a full insertion so that the filter engages into orifice and tapers into pump hole (vacuum port).In conclusion, the users must fully insert the filters; insertion of all barbs in may not be sufficient to prevent an air intake around the filter which will indicate to the pump that there is no full occlusion to suction, hence no need to alarm.While we have focused on additional dimensional verifications at vendor, we also want to reinforce proper system use to eliminate confusion of what the alarms are for: a backup to a visual line in canister (reason why the canister body is translucent and reference volume markings are indicated).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: 800CC SEALED CANNISTER
• 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: 3769684
• MDR Text Key: 4446280
• Report Number: 3006760724-2014-00296
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800423
• Device Lot Number: M400063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2011
• Distributor Facility Aware Date: 11/28/2011
• Event Location: Hospital
• Date Manufacturer Received: 11/28/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other