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

Model Number 66800796

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/03/2013

Event Type  malfunction  

Event Description

Dressings lifting; no leak alarm sounding.

Manufacturer Narrative

No pictures and/or lot number was provided for evaluation.A dhr review could not be initiated with the limited information provided.And, attempts to collect additional information from the complainant were not successful.The complaint describes a system connection involving five wounds.Two wounds were bridged with one soft port and three wounds were bridged together with one soft port.It was stated that the dressing was hovering over the wound and no leak alarm was triggered by the device.The use of a y-connector is recommended for two wounds with more than 25cm apart.As part of the recommendations, bridging two wounds which are greater than 25 cm apart should be accomplished using wound filler.There is not enough detail about the technique followed to determine if the wounds were properly bridged.There is no detail within the complaint to determine if the soft ports were tightly sealed at the initiation of the therapy.The complaint report indicates that the system was connected on friday and not monitored again until the following monday morning.It was observed that the patient had an output of 700 cc of serosanguinous drainage over the weekend.There is no detail of the monitoring of wound site during those three days although the description of the complaint documents high amounts of drainage.Proper clinical care should involve close monitoring of the dressing(s) when treating with a y-connector and higher amount of drainage is present and/or expected.It is likely that a clot may have formed beneath the dressing, at the head of the soft-port, or the drainage got thick enough that a barrier to exudate flow was created.A blockage and/ or clotting at the head of the soft port with the combination of a leak from the dressing exposed to the air will not be detected by the device and will not trigger an alarm if the alarm criteria are not met.The pump operates normally for leak rates up to a range of 2.5 -3.5 l/min but is designed to alarm for excessive leak if triggered by pressure differentials between pump pressure selector setting and the sustained pressure as measured by the device.T alarms in system connections normally occur within a period of time in the range of 3 minutes and are therefore not instantaneous.It is always recommended to regularly check the dressings to determine if more frequent dressing changes are required.In addition, a second renasys may also be utilized to handle the additional demand of the wound.In this scenario, the npwt system would continue to sense the presence of a vacuum, and continue to operate as expected.Although a definitive root cause could not be determined for the events described in this report, it is highly probable that a significant contributing factor is the attempted use of the device to provide therapy to 5 wounds.At this time this complaint investigation is deemed inconclusive based on the investigation into the limited information provided by the customer.Should additional information be provided, and/or the device returned for evaluation, smith & nephew will reopen this complaint and conduct further evaluation and investigation.

• Brand Name: RENASYS F LARGE 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: 3639900
• MDR Text Key: 4208711
• Report Number: 3006760724-2014-00010
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K110647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800796
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2013
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other