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

Model Number 66800933

Device Problems Device Alarm System (1012); Leak/Splash (1354); Suction Problem (2170)

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

Event Date 04/26/2012

Event Type  malfunction  

Event Description

Failure to maintain vacuum:wound has a leakage of exudate in the dressing and the pump is still working without alarming.

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 g small w/soft port.Smith & nephew received the above reported complaint for leakage of exudate in dressing.The kit lot number was provided, however samples or pictures were not available for evaluation.Since the negative pressure therapy involves various elements within a system, it is difficult to determine and assign a definitive root cause of the complaint described.The complaint is deemed undetermined.Possible root causes for leakage of exudate in dressing are: possible blockage caused by clotting at the head of the soft port with blood clots/exudate leading to leakage in dressing, blockage caused by pieces of loose transparent drape cut during preparation of the wound site leading to leakage in dressing, patient movement compromising wound seal or application techniques such as inappropriate wound/pump setting, soft port not totally aligned with hole cut in the transparent film or wound not completely sealed.There is no indication that a blockage or leakage alarm occurred by the description provided or that negative pressure therapy was not started or achieved.As a result of similar complaints 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 G SMALL 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: 3766351
• MDR Text Key: 19804278
• Report Number: 3006760724-2014-00290
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K110647
• 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
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800933
• Device Lot Number: 2012010210
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/26/2012
• Event Location: Hospital
• Date Manufacturer Received: 04/26/2012
• 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