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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER Back to Search Results
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.
 
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Brand NameCLEARSIGHT PRESSURE CONTROLLER KIT
Type of DeviceNON-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 Key7629619
MDR Text Key112029126
Report Number2015691-2018-02399
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPC2K
Device Catalogue NumberPC2K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
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

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