MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT; NON-INVASIVE CLEARSIGHT PUMP UNIT

Model Number EVPMP

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not been received yet.Upon the return of the product, a supplemental report will be submitted with the investigation results.The design history record review is pending and the results will be submitted by a supplemental report.The udi information for the pump unit is (b)(4).

Event Description

It was reported that there was a fire at the connection site of the clearsight pump unit and the power cord.This occurred during patient monitoring in the sicu.An investigation by the edwards field clinical specialist found that a saline bag was hanging over the components on the equipment pole at the time of the occurrence.There was no harm or injury to the patient or to hospital personnel.The hospital personnel have been provided information as to the proper placement of the equipment and to keep away from liquid.They have been provided clips to hang the equipment properly by the edwards cfs.The patient demographic information has not been provided.The power cord mdr will be submitted under a separate mdr submission.

Manufacturer Narrative

One clearsight pump unit was returned for product evaluation.The devices were examined and analyzed and it was identified that the source of the issue originated at the ac plug area entering into the pump unit.There is a burned area and a white crystalline material noted on the back and both sides of the unit.Higher magnification of the white residue suggests a white material with a crystalline structure.The eds indicates that the white residue consists of sodium and chlorine.This suggests the matrix is sodium chloride, a saline solution.The optical and sem/eds analysis of the devices suggests the issue was caused by a saline solution dripping and saturating the ac power plug that enters into the unit.The clearsight ifu in chapter 2 includes a warning that instructs the user, ¿do not allow any liquid to come in contact with the power connector.[or] allow any liquid to penetrate connectors or the openings in the case.¿ the edwards clinical field representative performed an in service visit to the facility and educated the hospital personnel on the proper way to hang the equipment on the equipment pole.She provided clips for the equipment.She advised ¿not to hang the saline bags above the equipment¿.This is not a systemic or design related issue.There is no indication that a manufacturing defect contributed to the failure.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The udi is (b)(4).Refer to the power cord submission 20155691-2018-04842.The reported event was confirmed by evaluation.The root cause is consistent with liquid ingress and customer mishandling.There will be no further actions taken at this time.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 a part of the monthly review.Additional information obtained from the hospital states that the patient was an unresponsive male patient in the sicu that was being monitored with a non-invasive a-line.When the incident occurred, the patient was evacuated from the room.There was no harm or injury to the patient.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CLEARSIGHT PUMP UNIT
• Type of Device: NON-INVASIVE CLEARSIGHT PUMP UNIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8094772
• MDR Text Key: 128578207
• Report Number: 2015691-2018-04841
• 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,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1