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

Model Number PC2K

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the investigation results.The device service history record review was completed and documented that the device met all specifications upon distribution.

Event Description

It was reported that while monitoring a patient during a neck surgery, there was a blood pressure reading discrepancy.There was a difference of 20 ¿ 30mmhg between the clearsight system and the nibp (non-invasive blood pressure).The patient also had an arterial line with a flotrac which correlated with the nibp.When the discrepancy was observed with the clearsight system, the clinician discontinued use of the system.There was no patient harm or injury.

Manufacturer Narrative

One pressure controller was received for product evaluation.The examination found that when the pressure controller was connected to a good working clearsight system, that there were no errors observed.The blood pressure readings that were displayed were normal readings.The fct1 and fct2 calibration tests were performed and the product passed both tests.There were no issues noted.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue was not confirmed by evaluation.There was no defect found.There are no indications that this is related to the manufacturing process.It could not be determined if any clinical or procedural factors may have contributed to the event.No further actions will be taken at this time.

• 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 ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5778615
• MDR Text Key: 49054447
• Report Number: 2015691-2016-02166
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2019
• Device Model Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• 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