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 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not been received yet.Upon return of the product a supplemental report will be submitted with the evaluation findings.

Event Description

It was reported that the clearsight pump unit displayed a blood pressure discrepancy.Compared to the radial arterial line, there was a 25% measurement discrepancy.This occurred while monitoring a patient.The patient was not treated with the inaccurate readings.There are no other suspect devices involved.There was no patient harm or injury.

Manufacturer Narrative

One clearsight pump unit was received for product evaluation.The examination found that the battery capacity was 0.The battery was charged overnight before testing.The suspect pump unit was tested using a known good working clearsight system and it passed the test.The ft4 calibration test was performed and it passed the test.The product performed normally.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.The device history record review was completed and all manufacturing inspections passed with no non conformances.The reported event was not confirmed by evaluation.There was no indication or evidence of a manufacturing defect being responsible for the issues.It could not be determined if any clinical or procedural factors may have contributed to the event.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 the monthly review.No further actions will be taken at this time.

• Brand Name: CLEARSIGHT PUMP UNIT
• Type of Device: NON-INVASIVE CLEARSIGHT PUMP UNIT
• 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: 6062072
• MDR Text Key: 58605520
• Report Number: 2015691-2016-03193
• 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: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2021
• Device Model Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1