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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
An investigation was done as a result of the inaccurate blood pressure reading that was received at this event. An edwards rn/bsn visited the facility to further investigate. She provided extensive education and training on the proper use of the products to the bio-medical and nursing staff at the hospital. It was determined that the end user had improperly placed the finger cuff on the patient and therefore, could not obtain an accurate bp reading. She demonstrated the proper set-up and use of the edwards ev1000ni clearsight system. The product will not be returned to edwards for evaluation. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. Please refer to three other submissions for the units involved; ev1000 platform, pressure controller, and evhrs unit.
 
Event Description
It was reported that while monitoring a patient with the non-invasive clearsight system the patient's blood pressure reading displayed on the ev1000ni monitor above 190 systolic. A manual blood pressure reading was then taken on the upper arm of the patient and the blood pressure reading was around 120 systolic. The physician removed the clearsight system and inserted an arterial line into the patient for monitoring. The patient was not treated with the inaccurate value. There was no patient harm or injury.
 
Manufacturer Narrative
There are other components that were involved in this event. Here are the submission report numbers: ev1000 platform 2015691-2016-00687 pressure controller 2015691-2016-00688 evhrs unit 2015691-2016-00689 finger cuff 2015691-2016-00720 in the initial report submitted on march 7, 2016, indicated that there were three other submissions for the units involved. That should be changed to four other submissions as listed above.
 
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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 Key5483770
MDR Text Key40114174
Report Number2015691-2016-00690
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 02/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/20/2020
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 Received02/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2015
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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