• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT NON-INVASIVE CLEARSIGHT PUMP UNIT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEARSIGHT PUMP UNIT
Type of DeviceNON-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 Key6756716
MDR Text Key194971747
Report Number2015691-2017-02284
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
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 Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-