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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 Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2017
Event Type  malfunction  
Manufacturer Narrative
One clearsight pump unit was received for product evaluation. The suspect pump unit was connected to a known good working clearsight system for analysis and testing. The system was able to perform zeroing successfully and there were normal blood pressure readings and normal waveforms that were obtained. The blood pressure readings were monitored for over one hour and there was a slight variation in the reading between 122/81 to 117/76. The ft4 calibration test was performed and it passed the test. There was no defect found. The device service history record review was completed and all manufacturing inspections passed with no non-conformances. The reported event could not be confirmed by evaluation. There is no evidence or indication that a manufacturing defect is responsible for the reported event. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. Pressure readings should correlate with the patient¿s clinical manifestations. Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements. The operators manual instructs the use on these above stated factors that can lead to inaccurate values. There was no patient treatment administered based on the static values. Is unknown if user or procedural factors contributed to the stated event. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
 
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received. The device history record has not yet been completed. Upon return of the product, a supplemental report will be submitted with the evaluation findings and upon completion, the dhr findings will be reported.
 
Event Description
It was reported that a clearsight pump unit was used during patient monitoring. It was noticed that the clearsight finger cuff blood pressure values were not correlating with the arm cuff blood pressure values. The finger cuff was 90mmhg to 100mmhg. The arm cuff was 120mmhg to 130mmhg. This was realized immediately by the edwards representative present during the procedure. There were no error messages observed. The finger cuff was exchanged and placed on the opposite hand and the issue did not resolve. The finger cuff was ruled out as suspect. Further investigation by the edwards representative found that there was dried saline residue on the pump unit port and roll stand. No other products were considered suspect. There was no inappropriate patient treatment administered. There was no harm or patient compromise.
 
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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
1 edwards way
irvine CA 92714
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key7023080
MDR Text Key249225503
Report Number2015691-2017-03800
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 10/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2019
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
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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