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

Model Number EVFTCL

Device Problem Incorrect Measurement (1383)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

As reported, during use in patient with this ev1000 flotrac cable, the central venous pressure (cvp) was 0 or way higher than the normal range.There was no allegation of patient injury.Follow up started for device return.

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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.The product is expected to be returned for analysis; however, it has not yet been received.

Manufacturer Narrative

Updated section h6 (type of investigation).Despite due diligent attempts to receive further information regarding this event or the associated device to be returned for evaluation, no additional information was received from the customer.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.

• 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; one edwards way; irvine CA 92614
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17142731
• MDR Text Key: 317317359
• Report Number: 2015691-2023-13925
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2023

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 Model Number: EVFTCL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 07/21/2023
• Supplement Dates FDA Received: 07/13/2023; 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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