MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT; NON-INVASIVE CLEARSIGHT PUMP UNIT

Model Number EVPMP

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation; however, the evaluation has not been completed.Upon receipt of the evaluation results a supplemental report will be submitted with the findings.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.(b)(4).

Event Description

It was reported that the clearsight pump unit was in use during patient monitoring when there were inaccurate blood pressure readings that displayed.The readings were 30 mmhg lower than the arm cuff reading display.The waveform displays were appropriate.The patient¿s blood pressure was in normal range throughout the case 120/70, per the arm cuff reading.The issue could not be isolated to either the pressure controller or the pump unit.The clearsight monitoring components were removed from the patient and not replaced.There was no inappropriate patient treatment administered.There was no patient harm or compromise.

Manufacturer Narrative

One clearsight pump unit was returned for product evaluation.The device was connected to a known good working clearsight system for analysis and testing.The system was booted up three times successfully without any errors identified.The known working heart reference sensor (hrs) was able to provide normal blood pressure readings and normal waveforms three different times without any issues noted.The functional test was performed and the pump unit 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.There was no previous servicing of this unit.The reported event was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.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 a part of the monthly review.The udi reference number is (b)(4).Refer to submission 2015691-2018-00554 for the pressure controller.

• Brand Name: CLEARSIGHT PUMP UNIT
• Type of Device: NON-INVASIVE CLEARSIGHT PUMP UNIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CO 92714
• MDR Report Key: 7278339
• MDR Text Key: 100489165
• Report Number: 2015691-2018-00553
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2022
• Device Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Date Manufacturer Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRESSURE CONTROLLER, BP ARM CUFF
• Patient Age: 59 YR
• Patient Weight: 116