MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT; NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER

Model Number PC2K

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned for examination and the evaluation is in progress.When the results are available a supplemental report will be submitted with the evaluation findings.The device service history record review has not been completed.A supplemental report will be submitted with the results.

Event Description

It was reported that the clearsight pressure controller was in use during patient monitoring when there were inaccurate blood pressure readings that displayed.There was a 20 ¿ 30 point difference between the arm cuff reading and the clearsight reading.The waveform display was appropriate.This was during use when it was found that the cuff 1 port was coated with a dried fluid and was not giving consistent blood pressure readings.When monitoring was switched to cuff 2 port, the pressure controller functioned correctly.The other clearsight monitoring components were confirmed to be placed correctly.The patient¿s arm was positioned appropriately.There were no error messages or alarms noted.When the pressure controller was exchanged for a different one, then the issue was resolved.There was no inappropriate patient treatment administered.The patient gender is female.No other patient demographics is available.There was no patient harm or compromise.The same pressure controller was used for monitoring another patient earlier that same day and the same issue occurred.A separate report will be submitted.

Manufacturer Narrative

One clearsight pressure controller device was returned for product evaluation.A visual inspection found that there was foreign residue on the external area of the device and between the housing and the frame.A functional examination was performed by connecting a patient simulator to the device.The cuff 1 port would not detect the patient simulator as connected.The cuff 2 port was able to recognize connectivity with the simulator; however, an error message was displayed when measurement readings were attempted.The device was disassembled and there was confirmation of internal residue.The cuff connector had residue that was consistent with liquid ingress.A microscopic examination was performed.The contamination source is possible blood or cleaning fluids that entered the device and damaged the printed circuit board assembly.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue of inaccurate blood pressure readings could not be confirmed due to the internal contamination of the device.User factors contributed to the stated event, there was no product malfunction.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.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.The clearsight manual includes a warning that instructs the user, ¿do not allow any fluids to enter the instrument.¿ it also instructs the user not to attempt to operate the platform if any of the components of the system come in contact with liquid.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.Refer to submission 2015691-2018-00555 for the first occurrence with the same pressure controller device.Udi reference number (b)(4).

• Brand Name: CLEARSIGHT PRESSURE CONTROLLER KIT
• Type of Device: NON-INVASIVE CLEARSIGHT PRESSURE CONTROLLER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92714
• MDR Report Key: 7278362
• MDR Text Key: 100511655
• Report Number: 2015691-2018-00556
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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: PC2K
• Device Catalogue Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BP ARM CUFF