MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number PC2K

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be evaluated; however, at the time of this report, the device has not been returned.A supplemental report will be submitted to communicate the results of the complaint investigation results.

Event Description

It was reported that during an orthopedic surgery of the knee, the systolic pressure was measured between 70 and 140 mmhg with the clearsight system, while the nibp (non-invasive blood pressure) was between 110 and 180 mmhg.The clinician believed that the nibp was the correct value.The pressure controller was exchanged for another pressure controller and the issue improved.The patient was not treated based on the perceived inaccurate values.No patient compromise was reported.No other system-related devices were reported as suspect.No patient demographics were able to be obtained.

Manufacturer Narrative

Examination of the returned pressure controller was unable to confirm the customer¿s complaint.Evaluation testing supports that the pressure controller functions as expected.However, another incident was identified; physical damage was detected in the housing by the pc2.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the use on these above stated factors that can lead to inaccurate values.It is unknown whether procedural processes or a specific circumstance played a role in the customer¿s experience, as the fault could not be replicated and no other issues were detected.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.No corrective or preventative actions are required at this time.

Manufacturer Narrative

The review of the device history record supports that there were no non-conformances noted for any reason and met all specifications upon distribution.

• Brand Name: CLEARSIGHT PRESSURE CONTROLLER KIT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6436281
• MDR Text Key: 70999422
• Report Number: 2015691-2017-00796
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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