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

Model Number 66800795

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250)

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

Event Date 07/09/2012

Event Type  malfunction  

Event Description

Failure to alarm: dressing soft port was compressed but dressing was leaking & canister was full, yet no canister full alarm noted on the renasys ez plus.

Manufacturer Narrative

This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the 483 issued november 26, 2013 to smith & nephew, inc.(b)(4).Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for complaints recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys f medium with soft port.Smith & nephew received the above reported complaint for no suction/failure to alarm.No samples, pictures or lot number information were provided or received for evaluation, therefore, a device history record review investigation could not be performed with the limited information provided.This complaint involves canisters not causing alarms when visibly full.The complaint is confirmed for canisters, as the alarm could not be readily observed after successful negative pressure therapy and full canister utilization.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 (same orifice design and tolerances).In all cases, full insertion is 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.Pump alarm must not replace clinical monitoring.Our recommendations for pump use indicate replacement of canisters when 2/3 full, and from what is reported, the usage is extended beyond this recommended safe level before replacement.Review for safety indicated that the completely-full 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.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 F MEDIUM WITH 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): WOUND US MANUFACTURING SITE; 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: 3761937
• MDR Text Key: 17390835
• Report Number: 3006760724-2014-00213
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800795
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/09/2012
• Event Location: Hospital
• Date Manufacturer Received: 07/09/2012
• 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