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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT NON-INVASIVE CLEARSIGHT PUMP UNIT Back to Search Results
Model Number EVPMP
Device Problem Fire (1245)
Patient Problem No Patient Involvement (2645)
Event Date 07/30/2017
Event Type  malfunction  
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 there were flames with a clearsight pump unit and the attached power cord. The origin was at the power connection on the back of the pump unit. This occurred during setup of the equipment. The nurse left the room and when he returned there were flames. He disconnected the power source and removed the unit from the patient room. The fire burnt itself out. The patient was present; however, monitoring of the patient had not begun. There was no harm or injury to the patient. There was no harm or injury to hospital personnel. There was no liquid involved that may have sparked the incident. This occurred before patient use; therefore, there are no patient demographics.
 
Manufacturer Narrative
One clearsight pump unit was received for product evaluation. The examination found that there was evidence of a fire at the pump unit and power cord connection area. The end of the power cord was melted and covered in soot. The power cord is scorched in the middle. There is damage to the power cord socket on the pump unit causing the two lugs from the power inlet in the socket to be stuck in the melted power cord. In addition, there is residue that was found around the pump unit that is consistent with liquid ingress. It was determined that the fire originated outside of the pump unit and was localized at the cable/power contact area; this is also consistent with liquid ingress. The root cause of the liquid ingress is customer mishandling. The clearsight ifu in chapter 2 includes a warning that instructs the user, ¿do not allow any liquid to come in contact with the power connector or allow any liquid to penetrate connectors or the openings in the case. ¿ this is not a systemic or design related issue. There is no indication that a manufacturing defect contributed to this failure. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. Refer to the power cord, 110v, submission number 2015691-2017-02538. The reported event was confirmed by evaluation. The root cause was determined to be customer mishandling. No further actions will be taken at this time.
 
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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
irvine CA 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key6806194
MDR Text Key83090801
Report Number2015691-2017-02539
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2020
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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