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 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis and the investigation is in progress.Upon return of the evaluation findings a supplemental report will be submitted.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.

Event Description

It was reported that while monitoring a patient, the clinicians observed that there was a 20 to 30 mmhg difference in the blood pressure reading when comparing the clearsight pump unit and the arm cuff reading.The numbers obtained from the clearsight pump unit were reading lower than the arm cuff reading.The pump unit was used on the same arm as the cuff and on the opposing arm.The patient was not treated with the inaccurate readings.There is no peripheral vascular disease noted.The perfusion was fine.There was no harm or injury to the patient.

Manufacturer Narrative

One non-invasive clearsight pump unit was received for product evaluation.Edwards¿ software designers analyzed the diagnostic log records.It did not reveal a root cause.The pump unit was setup with a known working system to run for testing for 24 hours at 8 hour segments.The engineers were unable to reproduce the reported issue.An external patient monitor was added to the working system to replicate the setup at the hospital and it ran for 72 hours.The engineers were unable to reproduce the reported issue.There were no defects found.After extensive testing, the issue was not confirmed by evaluation.There is no indication of a manufacturing defect that was noted during the analysis.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 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 ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5671077
• MDR Text Key: 45692788
• Report Number: 2015691-2016-01671
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

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: 03/07/2021
• Device Model Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1