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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 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
The product has been received for analysis and the investigation is in progress. Upon return of the evaluation findings a supplemental report will be submitted. The device service history record review was completed and there was an issue noted during production that was not related to the complaint issue. It was corrected and final inspection was passed.
 
Event Description
It was reported that while monitoring a patient, the clinicians observed that there was a 20 to 30 mmhg difference in the blood pressure reading when comparing the clearsight pump unit and the arm cuff reading. The numbers obtained from the clearsight pump unit were reading lower than the arm cuff reading. The pump unit was used on the same arm as the cuff and on the opposing arm. The patient was not treated with the inaccurate readings. There is no peripheral vascular disease noted. The perfusion was fine. There was no harm or injury to the patient.
 
Manufacturer Narrative
One non-invasive clearsight pump unit was received for product evaluation. Edwards¿ software designers analyzed the diagnostic log records. It did not reveal a root cause. The pump unit was setup with a known working system to run for testing for 24 hours at 8 hour segments. The engineers were unable to reproduce the reported issue. An external patient monitor was added to the working system to replicate the setup at the hospital and it ran for 72 hours. The engineers were unable to reproduce the reported issue. There were no defects found. After extensive testing, the issue was not confirmed by evaluation. There is no indication of a manufacturing defect that was noted during the analysis. It could not be determined if any clinical or procedural factors may have contributed to the event. 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 Key5671053
MDR Text Key45660318
Report Number2015691-2016-01670
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 04/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/07/2021
Device Model NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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