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

Model Number EVPMP

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

One clearsight pump unit was received for product evaluation. A known good working power cord was used with the suspect pump unit for analysis and testing. The power cord was inserted into the pump unit receptacle for testing. It was moved around vigorously while plugged in and there was no sparks, smoke or flames that were produced. The unit passed all safety and functional tests. Additionally, during evaluation, the dpt port nut was found to be missing, and the threads were damaged with glue residue found on them. This is not related to the alleged sparking event. The root cause of the dpt port thread damage is customer mishandling of the device. The reported event of sparks at the power cord connection was not confirmed. It could not be replicated through evaluation. No further actions will be taken at this time. The device service history record review was completed and all manufacturing inspections passed with no non-conformances.

Manufacturer Narrative

The device was returned for examination and the evaluation is in progress. Upon return of the evaluation results, a supplemental report will be submitted with the evaluation findings.

Event Description

It was reported that that there were sparks seen at the ev1000ni pump unit power cord connection. The edwards representative was providing an in-service training and education demonstration to the hospital staff when the event occurred. He was checking the loose connection on the pump unit and was re-plugging it back in when he observed the sparks. There was no liquid spilled or involved. There was no harm or injury to hospital personnel or edwards personnel. There was no patient involvement.

• 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; CA 92614
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6756716
• MDR Text Key: 194971747
• Report Number: 2015691-2017-02284
• 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

• Type of Report: Initial,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2021
• Device Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse