MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PRESSURE CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number EVFTC1

Device Problem Incorrect Measurement (1383)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

As reported, during use in patient with this expired ev1000 flotrac cable, incorrect map (mean arterial pressure), sbp (systolic blood pressure), dbp (diastolic blood pressure) values were displayed on the ev1000 monitor, while at the same time, the same values were clinically correct on a drager monitor.Then, the anesthetist attempted to re-zero the flotrac sensor, and the "selected ao zero point of our tolerance, check dpt" error message was displayed.As a troubleshooting, the co cable was unplugged and replaced with another shorter one to solve the issue.Later on, edwards field clinical specialist went on site to check the cable, and no issues were identified since the values remained within expected parameters, suggesting that this incident might have been caused by a loose connection, probably by moving the monitor intraoperatively.Anesthetist was informed about the troubleshooting to perform in case this issue reoccur.There was no allegation of patient injury.Patient demographics were requested but not available.The device was not available for evaluation since the issue did resolve after taking the cable out and plugging it back in.

Manufacturer Narrative

The device was not available for evaluation since the issue was solved.Therefore, a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.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: EDWARDS PRESSURE CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14236925
• MDR Text Key: 290797868
• Report Number: 2015691-2022-05446
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K191089
• 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: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

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: 12/02/2017
• Device Model Number: EVFTC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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