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

Model Number PC2K

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

The device 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.

Event Description

It was reported that during colorectal surgery, while monitoring a patient with the clearsight system; pump unit, pressure controller, heart reference sensor and ev1000ni system, there was a discrepancy in the systolic blood pressure reading.The reading measured 20-30 points different from the blood pressure cuff.There was also a discrepancy in the map values.The clearsight system components were removed from the patient when the discrepancy in values was observed.No troubleshooting was done to isolate a suspect component.The patient demographics are unknown.There was no treatment administered to the patient in conjunction with the inaccurate values.There was no harm or injury to the patient.

Manufacturer Narrative

One ev1000ni pressure controller unit was received for product evaluation.The pressure controller unit was connected to a known good working clearsight system for testing.The unit did not produce any issues when tested.It was able to perform zeroing three times on cuff 1 and on cuff 2 without any error messages.A visual inspection was completed and there was no physical damage observed.The calibration test was performed and it passed the test.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was not confirmed by evaluation.There are no indications or evidence that a manufacturing defect is responsible for the reported issue.It could not be determined if any procedural factors may have contributed to the event.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.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 further actions will be taken at this time.Please refer to 2015691-2016-03602 for the ev1000ni pump unit; 2015691-2016-03604 for the ev1000ni heart reference sensor unit; 2015691-2016-03605 for the ev1000a platform system associated with this event.

• Brand Name: CLEARSIGHT PRESSURE CONTROLLER KIT
• Type of Device: NON-INVASIVE 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: 6154234
• MDR Text Key: 61723523
• Report Number: 2015691-2016-03603
• 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,Followup
• Report Date: 11/22/2016

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 Expiration Date: 08/17/2021
• Device Model Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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
• Treatment: EV1000, PUMP UNIT, HRS UNIT, BP CUFF