MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800697

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problems Thrombus (2101); Complaint, Ill-Defined (2331); Blood Loss (2597)

Event Date 07/24/2013

Event Type  malfunction  

Event Description

Failure to alarm: in the past two weeks has had 3 incidents where a great deal of clotting had occurred beneath foam dressing and resulted in a large amount of blood under foam, not pulling through the foam.Dressing had lifted but failed to produce alarm.Nurse pam kirk at kaiser sacramento.She said that in the past two weeks she has had 3 incidents where a great deal of clotting had occurred beneath foam dressing and resulted in a large amount of blood under foam, not pulling through the foam.Dressing had lifted but failed to produce alarm.This patient was already compromised but his hemoglobin dropped to 6 and had lost a lot of blood during npwt therapy, but canister had not collected fluid because it had pooled beneath foam, so floor staff were not aware.This happened twice on same patient and one other time with a different patient.They have a combination of old soft ports and new ones.Pam believes they used the new soft port.They use the 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.Fei no: (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 ez plus.Smith & nephew received the above reported complaint for an adverse event.There were no pictures, no samples and no lot number information were provided for evaluation.A dhr review investigation could not be initiated with the limited product information provided, therefore, the complaint is deemed unconfirmed.Since the negative pressure therapy involves various elements within a system (i.E.Pump, canister, soft port etc.), it is difficult to determine and assign a definitive root cause of the complaint described.However, based on the information provided there is no data to clarify the existence of blood disorders, compromised hemostasis and/or usage of anti-coagulant therapy during npwt therapy or prior to npwt therapy.In these events, the development of a hematoma can create a partial occlusion in the soft port.Information contained within the clinical guidelines, regarding system blockage is as follows: when the system detects that the canister is full or that there is a blockage in the system, the audible alarm will sound and the status light will blink yellow.The blockage/canister full alarm will detect blockage from the wound to the canister when vacuum is set within the recommended therapeutic range (40-120mmhg).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 (b)(4).

• Brand Name: RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
• 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 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 ; 7273993785
• MDR Report Key: 3753672
• MDR Text Key: 4416176
• Report Number: 3006760724-2014-00102
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102001
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800697
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/24/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/24/2013
• Initial Date FDA Received: 04/16/2014
• 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