MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 NI PUMP UNIT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EVPMP

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The pump unit was repaired by the hospital and there have been no issues since the repair; however, edwards is following-up to get the unit returned for evaluation.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.

Event Description

As reported, smoke from the power socket of the pump unit was observed, at the beginning of the procedure with this pump unit as part of an ev1000ni system.No sparks nor fire were reported.Battery symbol was flicking on and off on the screen power display; however, monitor stayed on and the information also stayed.The device was replaced immediately when the issue was noticed.The appropriate cover was installed on the power cable socket of the pump unit.The used power cable was not an edwards device.The iec connector on the power appeared to have a dark build up at the neutral terminal (most likely melted plastic from the iec connector) and therefore, there was also dark build up on the neutral pin of the pump unit.There was no allegation of patient injury nor of the staff.

Manufacturer Narrative

We were further informed that customer did not want to return the device for examination.The evaluation completed by hospital vendor was reviewed and it stated that device failed safety test.The power cable was removed and it was found that neutral pin had been arcing.The cable was replaced and cleaned neutral pin on device.After that the device performed successfully with no issues.Based on investigation conducted by edwards engineers, is likely that the non edwards cable used caused the failure observed to happen.Per ev1000a manual, there are statements that mentions customer to use edwards power cable.These warnings are present in the manuals and the setup instructions.However, the device was not returned to an edwards service center for an approved investigation to determine the root cause.The findings based of the report provided by the hospital vendor stated that arcing was found.Arcing is a standard behavior and has no correlation to the smoke event observed by the hospital.Of note, the vendor report also suggested that replacing the cable (not specified as edwards cable) resolves the issue.There is not sufficient information provided in the event description and the report to determine the root cause of failure.There is no correlation made in the report for dark build up on the neutral pin and wrong cable used that could lead to smoke appearing in the device.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.

• Brand Name: EV1000 NI PUMP UNIT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12622553
• MDR Text Key: 276101148
• Report Number: 2015691-2021-05647
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

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 Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Device Lot Number: 600153016843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1