MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT; NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER

Model Number PC2K

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

The pressure controller was not returned for evaluation as the exact device involved in the event is not able to be identified.The device service history record review could not be completed as the serial number of the device is unknown.It should be noted that the ev1000 clinical platform ni, operator¿s manual states ¿wrap the pressure controller band around the patient¿s wrist and attach the pressure controller to the band.¿ the hospital staff has indicated that they do not use the pressure controller band when trying to secure a sterile field during a patient procedure.Edwards clinical field representative has notified them of the operator manual¿s instructions but the clinicians choose to use their own technique.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that a patient skin pressure sore/ulcer developed on the patient¿s wrist/arm area when using the clearsight pressure controller during patient monitoring.The patient stated there was soreness and pain two days later.The pressure controller was placed directly on the patient¿s arm/wrist without using the pressure controller band.The facility has their own process when using the clearsight system/pressure controller to secure a sterile field during surgery.The patient was undergoing an 8-16 hour breast free flap procedure with both arms prepped.They secure their monitoring equipment in their own manner with abd pads, 4x4¿s and tegaderm.A conversation was overheard in the or by an edwards clinical field representative between the surgeon and anesthesia team discussing the issue.The occurrence date is unknown.The patient demographic information is unknown.The exact pressure controller device used in the incident cannot be identified.Therefore, there is no product return.The patient¿s condition was described as a temporary issue.No further information was able to be obtained regarding the patient¿s current condition.There were three different patients with the same type of condition.The other two incidents will be reported via mdr submission.

• Brand Name: CLEARSIGHT PRESSURE CONTROLLER KIT
• Type of Device: NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7629619
• MDR Text Key: 112029126
• Report Number: 2015691-2018-02399
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PC2K
• Device Catalogue Number: PC2K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1