MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT EVNI PUMP UNIT

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.

Manufacturer Narrative

Initially the product evaluation identified that the cause of failure was a defective pump unit (internal component).After this assessment the pump unit was connected to a mockup system and all readings were stable.In addition the "defective" pump unit was re-installed into a known good pump unit and then passed all functional testing.Therefore, it is unlikely that the pump unit is defective.Based on additional information the likely cause of failure was a small leak between the pump unit and manifold which was likely resolved by removing and reinstalling a pump unit.The cause of failure is identified as a leak between the pump unit and manifold.A manufacturing issue was rejected as a root cause because the dhr was reviewed and no related manufacturing or servicing related nonconformance was identified.The pump component needs to be replaced during servicing if the pump run time > 21,600,000s.For this device the pump run time was 82,239s, so this failure is unlikely due to normal wear and tear.There is not enough evidence to confirm a design failure.There is no further investigation pending at this time.

• Brand Name: CLEARSIGHT EVNI PUMP UNIT
• Type of Device: PUMP UNIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10674201
• MDR Text Key: 213005159
• Report Number: 2015691-2020-13948
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1