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Model Number EVPMP
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
One pump unit was received for product evaluation. It was connected to a known good working clearsight system for testing. It booted up successfully and there were no errors observed. There were normal waveforms and normal blood pressure readings obtained while the system was running for over one hour. There was no loss of pressure and no error messages observed. The ft4 functional test was performed to verify the output pressure flows. The readings were not stable after 180 seconds. The values during the functional testing ranged from 313 to 355mmhg. When a stable reading could not be obtained there was an error generated of "error adaptation set pressure and measure stable, pressure not stabilized". All blood pressure readings were stable at 120/80. Once the pump inside the pump sub-assembly was replaced, the readings were stable after 15 seconds, ranging from 341 to 347mmhg. This occurred during product evaluation and not 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. Udi information is (b)(4).
Event Description
It was reported that the clearsight pump unit was being used with the clearsight system during patient monitoring. The clinician saw that there was no waveform display. However, the finger cuff was pulsating appropriately on the patient. To resolve the no waveform issue, the clinician exchanged the suspect pump unit for another one, using the same clearsight components and then everything worked fine. There was no patient injury.
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Type of DevicePUMP UNIT
Manufacturer (Section D)
one edwards way
irvine CA 92614
Manufacturer (Section G)
one edwards way
irvine CA 92614
Manufacturer Contact
jessica atallah
one edwards way
irvine, CA 92614
MDR Report Key10623913
MDR Text Key211448247
Report Number2015691-2020-13832
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/26/2021
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse