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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVNI PUMP UNIT

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EDWARDS LIFESCIENCES CLEARSIGHT EVNI 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 07/30/2020
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 testing. A patient monitor was being used. The system was left to run for an hour and there were no error messages present. The functional tester was performed and the device failed the pressure at various flows. The output pressure was at 150nl per hour and read 296. 8245mmhg. Limits are 337 to 350. The device was disassembled. The unit was removed from the manifold to check for any damage. There was no damage found. The device was re-assembled to the manifold and the test was performed again. The pressure at various flows then passed. The reported failure of "pump unit error" was not confirmed during evaluation; however, the device failed the functional tester as the output pressure was below the limits. This issue was identified during the product evaluation process and did not occur in a clinical setting. With any hemodynamic monitoring readings can change quickly and dramatically. Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions. In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. 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 the monthly review. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to the complaint. The device history record review was completed and all manufacturing inspections passed with no non-conformances. The udi information is (b)(4).
 
Event Description
It was reported that the clearsight pump unit was being used during patient monitoring and there was a display of a "pump unit error" message. The device stopped functioning during monitoring. A reboot of the system did not resolve the issue. There was no patient injury.
 
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Brand NameCLEARSIGHT EVNI PUMP UNIT
Type of DevicePUMP 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
jessica atallah
one edwards way
irvine, CA 92614
9492500294
MDR Report Key10674201
MDR Text Key213005159
Report Number2015691-2020-13948
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 07/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2018
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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