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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 Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2016
Event Type  malfunction  
Manufacturer Narrative
One clearsight pump unit was received for product evaluation. Edwards representatives from the operations and quality departments visited the hospital room where the event occurred. The team reviewed the pump unit and the environment and discussed with the hospital staff the circumstances surrounding the incident. Upon inspection, it was determined that the ac power inlet had caught fire and damaged the ac inlet and the power cord that was connected. It was further concluded that a saline bag with an open port that was positioned above the pump unit had been leaking. It was observed that there was significant saline flow at multiple points on the pump unit. There was salt build up observed above the ac inlet indicating that the saline fluid made its way into the ac connection of the pump unit. An internal inspection of the pump unit revealed that while there was smoke ingress, there was no damage to any internal component. The root cause of the incident was found to be excessive saline drip onto the unit and not due to an internal fault of the ev1000ni pump unit. There is no indication of a manufacturing defect that was noted during the analysis. The device service history record review was completed and documented that the device met all specifications upon distribution.
 
Event Description
It was reported that the clearsight pump unit was on an iv pole in a vacant room with an iv bag above it. There was no patient or hospital staff in the room. The hospital staff heard a noise and saw a flash and there was an electrical odor that was coming from the room. When they entered the room they saw smoke coming from the pump unit. The unit was unplugged from the wall. There was no patient involvement. There was no hospital staff harm or injury.
 
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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
one edwards way
irvine, CA 92614
9497564386
MDR Report Key5509408
MDR Text Key40842876
Report Number2015691-2016-00835
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
Report Date 02/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/03/2020
Device Model NumberEVPMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2015
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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