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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 11/22/2016
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for analysis; however, it has not been received yet. Upon return of the product for evaluation, a supplemental report will be submitted with the evaluation findings.
 
Event Description
It was reported that during colorectal surgery, while monitoring a patient with the clearsight system; pump unit, pressure controller, heart reference sensor and ev1000ni system, there was a discrepancy in the systolic blood pressure reading. The reading measured 20-30 points different from the blood pressure cuff. There was also a discrepancy in the map values. The clearsight system components were removed from the patient when the discrepancy in values was observed. No troubleshooting was done to isolate a suspect component. The patient demographics are unknown. There was no treatment administered to the patient in conjunction with the inaccurate values. There was no harm or injury to the patient.
 
Manufacturer Narrative
One ev1000ni pump unit was received for product evaluation. The pump unit was connected to a known good working clearsight system for testing. The pump unit did not produce any issues when tested. It was able to perform zeroing three times without any error messages. A normal waveform and normal blood pressure readings were able to be displayed three times without any issues noted. The 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 was not confirmed by evaluation. There are no indications or evidence that a manufacturing defect is responsible for the reported issue. It could not be determined if any procedural factors may have contributed to the 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. 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 part of this monthly review. No further actions will be taken at this time. Please refer to 2015691-2016-03603 for the ev1000ni pressure controller unit; 2015691-2016-03604 for the ev1000ni heart reference sensor; 2015691-2016-03605 for the ev1000a platform system associated with this event.
 
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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 92614
Manufacturer Contact
lynn selawski
1 edwards way
irvine, CA 92614
9497564386
MDR Report Key6154229
MDR Text Key61727227
Report Number2015691-2016-03602
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 11/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2021
Device Model NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/08/2016 Patient Sequence Number: 1
Treatment
EV1000 PLATFORM, PRESSURE CONTROLLER, HRS, BP CUFF
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