MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLER KIT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number PC2K

Device Problems Incorrect Measurement (1383); Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

The pressure controller was returned a technical service center for testing and it failed; receiving a value of 260.10mmhg out of 300mmhg.The product is expected to be returned to the manufacturer for further analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.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.

Event Description

As reported, during testing at a local service provider of this pressure controller, it was found that during the review test, the pressure in one channel did not stay at the level set on the tester level of 300mmhg.It decreased to the value of 268.51 mmhg.There was no allegation of patient injury.The pressure controller was returned a technical service center for testing and it failed; receiving a value of 260.10mmhg out of 300mmhg.

Manufacturer Narrative

The pressure controller was returned to the manufacturer for further evaluation.When it was connected to a known working system there were no errors.When a patient simulator was attached to cuff 2 and set to 120/80 the values returned were 130/80.When the same simulator was connected to cuff 1 it returned a reading of 121/81.When tested on the functional tester it failed several leak tests.Failed pressure cuff 2-1: at 233.1672 mmhg, (limits 300 to 350).Failed air leakage 1 at 32.4, (limits 0 to 12).Failed pressure cuff 2-2 at 241.5573 (limit 300 to 350).Failed air leakage 2 at 32.4, (limit 0 to 12).When a known working valve was installed on the cuff 2 side of the board, it passed all of the leak tests and calibration tests.It was then connected to the patient simulator and it gave a reading of 124/80.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this event.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CLEARSIGHT PRESSURE CONTROLER KIT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10016394
• MDR Text Key: 195067192
• Report Number: 2015691-2020-11744
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2019
• Device Model Number: PC2K
• Device Catalogue Number: PC2K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1